Kidney Canceri-RECORdNCT05363657
International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors
An observational study of Kidney Cancer, run by Azienda Ospedaliero-Universitaria Careggi at 37 sites in 13 countries.
Trial summary
Partial nephrectomy (PN) is the standard treatment for localized renal masses and should be preferred in clinical T1 (<7 cm tumor diameter) renal tumors over radical nephrectomy (RN) whenever technically feasible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Partial Nephrectomy (PN), Radical Nephrectomy (RN) and Ablation therapy (AT)
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 37 sitesin 13 countries
- Study dates
- 10 Jan 2022to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population include patients with a radiological diagnosis of kidney tumor susceptible to surgical treatment (RN or PN) or AT or WW/AS will be eligible.
Who may be able to join
- Radiological diagnosis of renal tumor susceptible to active treatment or AS/WW.
- Age ≥18 years
- Informed consent signed
Who cannot join
- Patient refuse to participate in clinical research.
- Urothelial renal carcinoma.
Trial locations and contacts
37 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
37 sites in 13 countries
Italy14 sites, 14 recruiting
- Recruiting
Urology, Andrology & Kidney Transplantation Unit, University of Bari
Bari, 70121
Pasquale Ditonno, pasquale.ditonno@uniba.it
- Recruiting
Policlinico S. Orsola Malpighi
Bologna, 40138
Riccardo Schiavina, rschiavina@yahoo.it
- Recruiting
Department of Urology, University of Florence, Unit of Oncologic Minimally-Invasive Urology and Andrology, Careggi Hospital
Florence, 50100
Andrea Mari, andrea.mari@unifi.it
- Recruiting
Policlinico Riuniti, Università di Foggia.
Foggia, 71122
Giuseppe Carrieri, giuseppe.carrieri@unifg.it
Gian Maria Busetto, gianmaria.busetto@unifg.it
- Recruiting
Division of Urology, University of Genoa,Policlinico San Martino Hospital
Genova, 16132
Carlo Terrone, carlo.terrone@med.uniupo.it
- Recruiting
Azienda Ospedaliera Policlinico "G. Martino", Università di Messina.
Messina, 98124
Vincenzo Ficarra, vficarra@unime.it
- Recruiting
San Raffaele Scientific Institute, Milan, Italy; Division of Experimental Oncology/Unit of Urology, URI, IRCCS San Raffaele Hospital
Milan, 20132
Umberto Capitanio, umbertocapitanio@gmail.com
- Recruiting
Policlinico Istituto Europeo di Oncologia (IEO)
Milan, 20141
Ottavio De Cobelli, Ottavio.DeCobelli@ieo.it
- Recruiting
Istituto Nazionale dei Tumori Fondazione Senatore "G. Pascale"
Naples, 80131
Sisto Perdona', s.perdona@istitutotumori.na.it
- Recruiting
Institute Oncology Veneto (IOV)
Padova, 35128
Angelo Porreca, angeloporreca@gmail.com
- Recruiting
Humanitas Hospital
Rozzano, 20089
Nicolomaria Buffi, nicolo.buffi@hunimed.eu
- Recruiting
Università degli Studi di Torino, Ospedale S. Luigi Gonzaga.
Torino, 10043
Francesco Porpiglia, porpiglia@libero.it
- Recruiting
Università degli studi di Torino, Ospedale Molinette
Torino, 10126
Paolo Gontero, paolo.gontero@unito.it
- Recruiting
AOUI Verona
Verona, 37126
Alessandro Antonelli, alessandro.antonelli@me.com
United States7 sites, 7 recruiting
- Not yet recruiting
Loyola University Medical Center, Edward Hines VA Hospital
Chicago, Illinois, 60141
Gopal Gupta, GOGUPTA@lumc.edu
- Recruiting
Institute of Urology, University of Southern California.
Los Angeles, California, 90007
Giovanni E Cacciamani, giovanni.cacciamani@med.usc.edu
- Not yet recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Philip Pierorazio, Phillip.Pierorazio@pennmedicine.upenn.edu
- Recruiting
VCU Health System
Richmond, Virginia, 23298
Riccardo Autorino, ricautor@gmail.com
- Recruiting
University of California San Diego, Moores Cancer Center
San Diego, California, 92037
Ithaar Derweesh, iderweesh@gmail.com
- Not yet recruiting
Swedish Hospital
Seattle, Washington, 98122
James Porter, porter@swedishurology.com
- Not yet recruiting
Stanford University
Stanford, California, 94304
Benjamin I Chung, bichung@stanford.edu
Belgium3 sites, 3 recruiting
- Recruiting
University of Bruxelles
Brussels, 1050
Simone Albisinni, albisinni.simone@gmail.com
- Not yet recruiting
University Hospitals Leuven
Leuven, 3000
Maarten Albersen, maarten.albersen@uzleuven.be
- Recruiting
Onze Lieve Vrouw Hospital
Leuven, 8500
Geert De Naeyer, geertdenaeyer@yahoo.com
Poland2 sites, 2 recruiting
- Recruiting
European Health Center
Otwock, 05-400
Lukasz Nyk, ukinyk@poczta.fm
Hubert Kamecki, hubert@kamecki.pl
- Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie
Warsaw, 00-001
Roman Sosnowski, roman.sosnowski@gmail.com
Spain2 sites, 2 recruiting
- Recruiting
Fundaciò Puigvert
Barcelona, 08025
Joan Palou, ipalou@fundacio-puigvert.es
- Recruiting
Hospital Universitario Ramón y Cajal, University of Alcalá
Madrid, 28034
Vital Hevia, vital.hevia.uro@gmail.com
United Kingdom2 sites, 2 recruiting
- Recruiting
Bristol Urological Institute
Bristol, BS10 5NB
Francis Keeley, Francis.Keeley@nbt.nhs.uk
- Recruiting
Guy's Hospital
London, SE1 9RT
Ben Challacombe, benchallacombe@doctors.org.uk
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna, Vienna General Hospital
Vienna, 1090
Shahkrokh F Shariat, shahrokh.shariat@meduniwien.ac.at
Brazil1 site, 1 recruiting
- Recruiting
Santa Casa da Misericórdia de Fortaleza
Fortaleza, 60025
Francisco Hidelbrando A Mota Filho, fha.motafilho@gmail.com
Greece1 site, 1 recruiting
- Recruiting
University of Patras
Pátrai, 265 04
Evangelos Liatsikos, liatsikos@yahoo.com
Japan1 site, 1 recruiting
- Not yet recruiting
Jikei University School of Medicine
Tokyo, 105-8461
Shin Egawa, s-egpro@jikei.ac.jp
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam University Medical Centers
Amsterdam, 1118
Axel Bex, a.bex@nki.nl
Russia1 site, 1 recruiting
- Recruiting
N.N. Blokhin National Medical Research Center of Oncology
Moscow, 119571
Vsevolod Matveev, vsevolodmatveev@mail.ru
Singapore1 site, 1 recruiting
- Recruiting
NG Teng Fong General Hospital
Singapore, 6090606
Vineet Gaauhaar, vineetgaauhaar@gmail.com
About this study
Official title: International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors (i-RECORd)
Partial nephrectomy (PN) is the standard treatment for localized renal masses and should be preferred in clinical T1 (<7 cm tumor diameter) renal tumors over radical nephrectomy (RN) whenever technically feasible. Nonetheless, indications, approaches, techniques for PN, and correct reporting of outcomes, are still a matter of great debate within the urology community. Concurrently, case-report series suggested that alternative strategies for the treatment of localized renal tumors (ablation techniques (AT), watchful waiting (WW), active surveillance (AS)) could be feasible with acceptable oncologic outcomes in particular settings of patients with localized renal tumors. In this complex clinical scenario, the role surgeon-related and environmental factors (such as surgical experience, hospital resources, countries' social background and performance of health system) are important to address the best personalized approach in patients with renal tumors.
In the light of current evidence, many unsolved questions still remain and many unmet needs must be addressed. In particular, 1) the risk-benefit trade-offs between PN and RN for anatomically complex renal localized tumors; 2) the definition of evidence-based strategies to tailor the management strategy (AT vs WW vs AS vs surgery) in different subset of patients with particular clinical conditions (i.e. old, frail, comorbid patients); and 3) the definition of evidence-based recommendations to adapt surgical approach (open vs laparoscopic vs robotic) and resection techniques to different patient-, tumor-, and surgeon-specific characteristics.
Read more
To meet the challenges, to overcome the limitations of current kidney cancer literature (such as the retrospective study design, potential risk of biases, and heterogeneous follow-up of most series), and to provide high-quality evidence for future development of effective clinical practice Guidelines, we designed the international REgistry of COnservative or Radical treatment of localized kiDney tumors (i-RECORD) Project.
The expected impact of the i-RECORD project is to provide robust evidence on the leading clinical and environmental factors driving selection of the management strategy in patients with kidney cancer, and the differential impact of different management strategies (including AS, WW, AT, PN and RN) on functional, perioperative and oncological outcomes, as well as quality of life assessment, at a mid-long term follow-up (5-10 years).
Read the detailed description
Study design
The overall objective of the i-RECORD project is to build a multicentre multi-arm multi-stage prospective observational registry collecting data on the management of kidney cancer in consecutive patients treated at 50 tertiary referral Centers worldwide over a 2 years-period and with 5 years of follow-up
. On this registry, six prospective trials with specific objectives have been built.
The i-RECORd project is designed as an observational prospective longitudinal trial involving 50 international, very-high-volume tertiary referral Centers with extensive experience in management of kidney cancer. Centers will be included in the project only if they will be able to certify at least to: 1) perform 150 partial and radical nephrectomy/year, or 2) to perform 80 ATs/year, or 3) to include 50 patients in WW/AS protocols/year.
The enrollment and follow-up periods will be 2 and 5 years, respectively. The estimate of patients' enrollment over the study period is 10'000 inclusions.
The 50 Centers finally enrolled in the i-RECORD project will be given the access to a web-based platform for data collection for 24 months from the starting date of the project.
A web-based e-form platform will be used for data collection.
Data collection
This observational study aims to obtain controlled, qualitative and quantitative, data of the enrolled patients through a web-based e-form platform. For all patients it will be asked to complete a data collection form specifically designed for this study, consisting of some subfolders:
- Anthropometric, pre-operative and comorbidity data (patient characteristics).
- Imaging data e and pre-operative tumor features (tumor characteristics).
- Intra-operative and post-operative data (treatment characteristics).
- Histopathological analysis (tumor histopathological characteristics).
- Patients follow-up variables (at 6, 12, 24 and 60 months from the treatment) (follow-up characteristics).
Decision Analysis Modeling
Beyond traditional descriptive and inferential statistical analyses, the i-RECORd project will provide a comprehensive overview of the current selection criteria for each type of management option by applying innovative statistical methods (Decision Analysis Modeling through discrete choice models) to determine the differential impact of all potential relevant variables on the choice of treatment. To do so, we will consider specific clinical scenarios (clinical clusters) made of the integration of patient characteristics (comorbidity score, performance status, age, gender, etc.), patient-reported outcomes measures (PROMs), tumors anatomical features (degree of complexity, clinical diameter, side, location within the kidney, involvement of renal sinus or collecting system, etc.), surgeon-related factors (surgical experience and background), hospital economic availabilities (i.e. open, laparoscopic, robotic surgery) and other country-specific socio-economical features in order to determine the impact of such variables on the final choice of treatment.
By applying the discrete choice model to the analysis of the prospective dataset, the i-RECORd project will overcome the current state of the art in the treatment of localized renal tumors as it will show how the choice of treatment is performed by the decision-maker (at a surgeon- and hospital-level) in each specific clinical cluster of patients, why that choice was performed according to a careful analysis of the personalized patient setting and whether that choice will influence the postoperative outcomes.
Adapted MAMS Registry
The i-RECORD will be designed adapting the innovative concept of multi-arm, multi-stage (MAMS) platform randomized trials (used, for instance, for the design of the Systemic Therapy in Advancing or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) Trial) to create a dynamic, observational registry evaluating simultaneously different management options in different patient- and/or tumor-related scenarios.
- Conditions
- Kidney Cancer
- Being tested
- Partial Nephrectomy (PN), Radical Nephrectomy (RN), Ablation therapy (AT), Active Surveillance (AS)
- Keywords
- Kidney cancer, Partial Nephrectomy, Radical Nephrectomy, Ablation Techniques, Active Surveillance, Recurrence Free Survival, Watchful Waiting
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial Nephrectomy (PN)Procedure or surgery
Conservative removal of kidney tumor. The procedure can be performed either with an open or laparoscopic or robotic approach.
Radical Nephrectomy (RN)Procedure or surgery
Surgical removal of the affected kidney. Adrenal removal can be performed according to surgeon choice and clinical characteristics of the renal tumor. The procedure can be performed either with an open or laparoscopic or robotic approach.
Ablation therapy (AT)Procedure or surgery
The procedure of tumor ablation performed with radiofrequency or cryoablation. The procedure can be performed either with a laparoscopic approach or percutaneous access.
Active Surveillance (AS)Diagnostic test
Active surveillance is defined as the initial management including the monitoring of renal tumor size by serial imaging with delayed treatment in case of progression.
| Study group | Role | What they receive |
|---|---|---|
| Renal tumor patiens | Patients with any renal tumor diagnosed with conventional imaging (computed tomography or magnetic resonance imaging) and undergoing to a clinical management in a hugh-volume center. Receives: Procedure: Partial Nephrectomy (PN); Procedure: Radical Nephrectomy (RN); Procedure: Ablation therapy (AT); Diagnostic Test: Active Surveillance (AS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the effectiveness of partial nephrectomy for the treatment of localized renal tumors (T1-T2N0M0) with regards to recurrence-free survival and cardiovascular accidents and mortality in comparison to radical nephrectomy?
The preoperative characteristics of the patients will be specifically evaluated to calculate any heterogeneity between the two groups. In detail, anthropometric and comorbidity features, previous abdominal surgery, blood chemistry values, blood pressure, smoking habit, preoperative life expectancy, and frailty grade will be assessed. Imaging features of the tumor will be considered, including the characteristics necessary for the calculation of the PADUA, R.E.N.A.L., and Contact-Surface-Area scores. Patients with a node-positive or metastatic disease diagnosed with conventional imaging (CT scan/MRI) will be excluded. Intra-operative and post-operative outcomes will be evaluated. Histopathological features of the tumor will be assessed.
Patients will be followed up with conventional imaging according to the International guidelines (ultrasound, CT, MRI). Serum creatinine, platelets and estimated glomerular function (eGFR), the onset of cardiovascular adverse events will be registered.
Measured: Assesments of the outcome at 60 months from the surgical intervention. Time frame : 5 years
To test the effectiveness of robotic approach in partial nephrectomy to increase the "Trifecta" rate after nephron-sparing surgery in patients with T1-T2N0M0 renal tumors.
"Trifecta" rate is defined as 1) Absence of intraoperative and postoperative surgical complications; 2) absence of positive surgical margins or recurrences on tumor resection site during a 5-year follow-up; 3) Absence of clinically significant renal function loss at one year after surgery. Renal function will be evaluated using the estimated glomerular filtration rate (eGFR) in ml/min/1.73 m^2 using the CKD-EPI Creatinine Equation (2021). A clinically significant loss will be considered if >25% from eGFR at baseline.
The "Trifecta" outcome will be evaluated one year from surgery.
Measured: Assesment of the "Trifecta" outcome will be performed at 12 months from the surgical intervention. Time frame: 1 year.
Secondary outcomes (3)
To evaluate the differential impact of patients' comorbidities, tumors' complexity, surgeons' experience, country-related socio-cultural factors and hospital financial resources on the selection of the type of clinical management.
The following variables will be evaluated:
- Anthropometric, pre-operative and comorbidity data (patient characteristics).
- Imaging data and pre-operative tumor features (tumor characteristics).
- Centre facilities (laparoscopic/robot assisted, interventional radiology) , volume centre (PN/RN ratio, availability of Multidisciplinary Tumor Board)
- Intra-operative and post-operative data (treatment characteristics).
- Histopathological analysis (tumor histopathological characteristics). The outcome will be considered as the type of clinical management selected: active surveillance (AS) vs ablative treatment (AT) vs partial nephrectomy (PN) vs radical nephrectomy (RN).
Measured: Assesment will be done at the time of registering the type of surgery/clinical managing adopted. Time frame: <1 week from patients accrual..
To evaluate the impact of the antiaggregant and/or antiplatelet treatment at baseline and during partial nephrectomy on hemorrhagic complications.
The eventual anticoagulant therapy (heparin, warfarin, enoxaparin, fondaparinux) and/or antiplatelet therapy (clopidogrel, ticagrelor, prasugrel, dipyridamole, dipyridamole/aspirin, ticlopidine, eptifibatide) use in patients at baseline and at time of surgery will be assessed.
Hemorrhagic complications (graded according to the "Clavien-Dindo classification") will be evaluated during surgery (intraoperative) and within 90 days (postoperative) with particular attention to the management of hemorrhage (patient monitoring, transfusion, selective embolization, re-intervention with/without kidney removal).
Measured: Outcome assesment will be done at 90 days from surgery. Time frame: 3 months
To assess in patients with antiaggregant and/or antiplatelet treatment at baseline any potential change of this therapy at the time of treatment associated with the absence of hemorrhagic complications.
The eventual anticoagulant therapy (heparin, warfarin, NAO, enoxaparin, fondaparinux) and/or antiplatelet therapy (clopidogrel, ticagrelor, prasugrel, dipyridamole, dipyridamole/aspirin, ticlopidine, eptifibatide) use in patients at baseline and at time of surgery will be assessed.
Change of treatment from baseline to time of surgery will be considered and specifically evaluated according to the underlying cardio- and/or peripheral- and/or cerebro-vascular diseases.
Measured: Outcome assesment will be done at 90 days from surgery. Time frame: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start10 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Collaborators
- Società Italiana di Urologia (SIU), Italian Group for Advanced Laparo-Endoscopic and Robotic Urologic Surgery (AGILE)
- Responsible party
- Principal investigator, Andrea Minervini, Azienda Ospedaliero-Universitaria Careggi
- Investigators
- Andrea Minervini, Prof., Principal investigator, Dipartimento di Medicina Clinica e Sperimentale Via o Piazza Largo Brambilla 3 - 50134 Firenze (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363657
- Sponsor's protocol ID
- i-RECORd
- Acronym
- i-RECORd
- Status last verified
- May 2022
- First submitted
- 14 Mar 2022
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol has been shared on the web platform of the i-RECORd project. The study has been shared with a specific Twitter page for the study.
Publications
Ljungberg B, Bensalah K, Canfield S, Dabestani S, Hofmann F, Hora M, Kuczyk MA, Lam T, Marconi L, Merseburger AS, Mulders P, Powles T, Staehler M, Volpe A, Bex A. EAU guidelines on renal cell carcinoma: 2014 update. Eur Urol. 2015 May;67(5):913-24. doi: 10.1016/j.eururo.2015.01.005. Epub 2015 Jan 21.
PubMed 25616710Global Burden of Disease Cancer Collaboration; Fitzmaurice C, Allen C, Barber RM, Barregard L, Bhutta ZA, Brenner H, Dicker DJ, Chimed-Orchir O, Dandona R, Dandona L, Fleming T, Forouzanfar MH, Hancock J, Hay RJ, Hunter-Merrill R, Huynh C, Hosgood HD, Johnson CO, Jonas JB, Khubchandani J, Kumar GA, Kutz M, Lan Q, Larson HJ, Liang X, Lim SS, Lopez AD, MacIntyre MF, Marczak L, Marquez N, Mokdad AH, Pinho C, Pourmalek F, Salomon JA, Sanabria JR, Sandar L, Sartorius B, Schwartz SM, Shackelford KA, Shibuya K, Stanaway J, Steiner C, Sun J, Takahashi K, Vollset SE, Vos T, Wagner JA, Wang H, Westerman R, Zeeb H, Zoeckler L, Abd-Allah F, Ahmed MB, Alabed S, Alam NK, Aldhahri SF, Alem G, Alemayohu MA, Ali R, Al-Raddadi R, Amare A, Amoako Y, Artaman A, Asayesh H, Atnafu N, Awasthi A, Saleem HB, Barac A, Bedi N, Bensenor I, Berhane A, Bernabe E, Betsu B, Binagwaho A, Boneya D, Campos-Nonato I, Castaneda-Orjuela C, Catala-Lopez F, Chiang P, Chibueze C, Chitheer A, Choi JY, Cowie B, Damtew S, das Neves J, Dey S, Dharmaratne S, Dhillon P, Ding E, Driscoll T, Ekwueme D, Endries AY, Farvid M, Farzadfar F, Fernandes J, Fischer F, G/Hiwot TT, Gebru A, Gopalani S, Hailu A, Horino M, Horita N, Husseini A, Huybrechts I, Inoue M, Islami F, Jakovljevic M, James S, Javanbakht M, Jee SH, Kasaeian A, Kedir MS, Khader YS, Khang YH, Kim D, Leigh J, Linn S, Lunevicius R, El Razek HMA, Malekzadeh R, Malta DC, Marcenes W, Markos D, Melaku YA, Meles KG, Mendoza W, Mengiste DT, Meretoja TJ, Miller TR, Mohammad KA, Mohammadi A, Mohammed S, Moradi-Lakeh M, Nagel G, Nand D, Le Nguyen Q, Nolte S, Ogbo FA, Oladimeji KE, Oren E, Pa M, Park EK, Pereira DM, Plass D, Qorbani M, Radfar A, Rafay A, Rahman M, Rana SM, Soreide K, Satpathy M, Sawhney M, Sepanlou SG, Shaikh MA, She J, Shiue I, Shore HR, Shrime MG, So S, Soneji S, Stathopoulou V, Stroumpoulis K, Sufiyan MB, Sykes BL, Tabares-Seisdedos R, Tadese F, Tedla BA, Tessema GA, Thakur JS, Tran BX, Ukwaja KN, Uzochukwu BSC, Vlassov VV, Weiderpass E, Wubshet Terefe M, Yebyo HG, Yimam HH, Yonemoto N, Younis MZ, Yu C, Zaidi Z, Zaki MES, Zenebe ZM, Murray CJL, Naghavi M. Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-years for 32 Cancer Groups, 1990 to 2015: A Systematic Analysis for the Global Burden of Disease Study. JAMA Oncol. 2017 Apr 1;3(4):524-548. doi: 10.1001/jamaoncol.2016.5688.
PubMed 27918777Campbell S, Uzzo RG, Allaf ME, Bass EB, Cadeddu JA, Chang A, Clark PE, Davis BJ, Derweesh IH, Giambarresi L, Gervais DA, Hu SL, Lane BR, Leibovich BC, Pierorazio PM. Renal Mass and Localized Renal Cancer: AUA Guideline. J Urol. 2017 Sep;198(3):520-529. doi: 10.1016/j.juro.2017.04.100. Epub 2017 May 4.
PubMed 28479239Stewart SB, Thompson RH, Psutka SP, Cheville JC, Lohse CM, Boorjian SA, Leibovich BC. Evaluation of the National Comprehensive Cancer Network and American Urological Association renal cell carcinoma surveillance guidelines. J Clin Oncol. 2014 Dec 20;32(36):4059-65. doi: 10.1200/JCO.2014.56.5416. Epub 2014 Nov 17.
PubMed 25403213Motzer RJ, Jonasch E, Agarwal N, Bhayani S, Bro WP, Chang SS, Choueiri TK, Costello BA, Derweesh IH, Fishman M, Gallagher TH, Gore JL, Hancock SL, Harrison MR, Kim W, Kyriakopoulos C, LaGrange C, Lam ET, Lau C, Michaelson MD, Olencki T, Pierorazio PM, Plimack ER, Redman BG, Shuch B, Somer B, Sonpavde G, Sosman J, Dwyer M, Kumar R. Kidney Cancer, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2017 Jun;15(6):804-834. doi: 10.6004/jnccn.2017.0100.
PubMed 28596261Volpe A, Blute ML, Ficarra V, Gill IS, Kutikov A, Porpiglia F, Rogers C, Touijer KA, Van Poppel H, Thompson RH. Renal Ischemia and Function After Partial Nephrectomy: A Collaborative Review of the Literature. Eur Urol. 2015 Jul;68(1):61-74. doi: 10.1016/j.eururo.2015.01.025. Epub 2015 Feb 20.
PubMed 25703575Finelli A, Ismaila N, Bro B, Durack J, Eggener S, Evans A, Gill I, Graham D, Huang W, Jewett MA, Latcha S, Lowrance W, Rosner M, Shayegan B, Thompson RH, Uzzo R, Russo P. Management of Small Renal Masses: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2017 Feb 20;35(6):668-680. doi: 10.1200/JCO.2016.69.9645. Epub 2017 Jan 17.
PubMed 28095147Larcher A, Sun M, Dell'Oglio P, Trudeau V, Boehm K, Schiffmann J, Tian Z, Fossati N, Capitanio U, Briganti A, Montorsi F, Karakiewicz P. Mortality, morbidity and healthcare expenditures after local tumour ablation or partial nephrectomy for T1A kidney cancer. Eur J Surg Oncol. 2017 Apr;43(4):815-822. doi: 10.1016/j.ejso.2016.08.023. Epub 2016 Sep 17.
PubMed 27692535Larcher A, Fossati N, Tian Z, Boehm K, Meskawi M, Valdivieso R, Trudeau V, Dell'Oglio P, Buffi N, Montorsi F, Guazzoni G, Sun M, Karakiewicz PI. Prediction of Complications Following Partial Nephrectomy: Implications for Ablative Techniques Candidates. Eur Urol. 2016 Apr;69(4):676-682. doi: 10.1016/j.eururo.2015.07.003. Epub 2015 Jul 21.
PubMed 26206408Kim SP, Campbell SC, Gill I, Lane BR, Van Poppel H, Smaldone MC, Volpe A, Kutikov A. Collaborative Review of Risk Benefit Trade-offs Between Partial and Radical Nephrectomy in the Management of Anatomically Complex Renal Masses. Eur Urol. 2017 Jul;72(1):64-75. doi: 10.1016/j.eururo.2016.11.038. Epub 2016 Dec 14.
PubMed 27988238Patel HD, Pierorazio PM, Johnson MH, Sharma R, Iyoha E, Allaf ME, Bass EB, Sozio SM. Renal Functional Outcomes after Surgery, Ablation, and Active Surveillance of Localized Renal Tumors: A Systematic Review and Meta-Analysis. Clin J Am Soc Nephrol. 2017 Jul 7;12(7):1057-1069. doi: 10.2215/CJN.11941116. Epub 2017 May 8.
PubMed 28483780Mari A, Campi R, Schiavina R, Amparore D, Antonelli A, Artibani W, Barale M, Bertini R, Borghesi M, Bove P, Brunocilla E, Capitanio U, Da Pozzo L, Daja J, Gontero P, Larcher A, Li Marzi V, Longo N, Mirone V, Montanari E, Pisano F, Porpiglia F, Simeone C, Siracusano S, Tellini R, Trombetta C, Volpe A, Ficarra V, Carini M, Minervini A; Collaborators. Nomogram for predicting the likelihood of postoperative surgical complications in patients treated with partial nephrectomy: a prospective multicentre observational study (the RECORd 2 project). BJU Int. 2019 Jul;124(1):93-102. doi: 10.1111/bju.14680. Epub 2019 Feb 12.
PubMed 30653796Psutka SP, Leibovich BC. Management of inferior vena cava tumor thrombus in locally advanced renal cell carcinoma. Ther Adv Urol. 2015 Aug;7(4):216-29. doi: 10.1177/1756287215576443.
PubMed 26445601Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
PubMed 16129869Sydes MR, Parmar MK, Mason MD, Clarke NW, Amos C, Anderson J, de Bono J, Dearnaley DP, Dwyer J, Green C, Jovic G, Ritchie AW, Russell JM, Sanders K, Thalmann G, James ND. Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial. Trials. 2012 Sep 15;13:168. doi: 10.1186/1745-6215-13-168.
PubMed 22978443
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors (i-RECORd)
- ClinicalTrials.gov ID
- NCT05363657
- Acronym / sponsor ID
- i-RECORd / i-RECORd
- Conditions
- Kidney Cancer
- Keywords
- Kidney cancer, Partial Nephrectomy, Radical Nephrectomy, Ablation Techniques, Active Surveillance, Recurrence Free Survival, Watchful Waiting
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Collaborators
- Società Italiana di Urologia (SIU), Italian Group for Advanced Laparo-Endoscopic and Robotic Urologic Surgery (AGILE)
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Partial nephrectomy (PN) is the standard treatment for localized renal masses and should be preferred in clinical T1 (<7 cm tumor diameter) renal tumors over radical nephrectomy (RN) whenever technically feasible. Nonetheless, indications, approaches, techniques for PN, and correct reporting of outcomes, are still a matter of great debate within the urology community. Concurrently, case-report series suggested that alternative strategies for the treatment of localized renal tumors (ablation techniques (AT), watchful waiting (WW), active surveillance (AS)) could be feasible with acceptable oncologic outcomes in particular settings of patients with localized renal tumors. In this complex clinical scenario, the role surgeon-related and environmental factors (such as surgical experience, hospital resources, countries' social background and performance of health system) are important to address the best personalized approach in patients with renal tumors.
In the light of current evidence, many unsolved questions still remain and many unmet needs must be addressed. In particular, 1) the risk-benefit trade-offs between PN and RN for anatomically complex renal localized tumors; 2) the definition of evidence-based strategies to tailor the management strategy (AT vs WW vs AS vs surgery) in different subset of patients with particular clinical conditions (i.e. old, frail, comorbid patients); and 3) the definition of evidence-based recommendations to adapt surgical approach (open vs laparoscopic vs robotic) and resection techniques to different patient-, tumor-, and surgeon-specific characteristics.
To meet the challenges, to overcome the limitations of current kidney cancer literature (such as the retrospective study design, potential risk of biases, and heterogeneous follow-up of most series), and to provide high-quality evidence for future development of effective clinical practice Guidelines, we designed the international REgistry of COnservative or Radical treatment of localized kiDney tumors (i-RECORD) Project.
The expected impact of the i-RECORD project is to provide robust evidence on the leading clinical and environmental factors driving selection of the management strategy in patients with kidney cancer, and the differential impact of different management strategies (including AS, WW, AT, PN and RN) on functional, perioperative and oncological outcomes, as well as quality of life assessment, at a mid-long term follow-up (5-10 years).
Detailed description
Study design
The overall objective of the i-RECORD project is to build a multicentre multi-arm multi-stage prospective observational registry collecting data on the management of kidney cancer in consecutive patients treated at 50 tertiary referral Centers worldwide over a 2 years-period and with 5 years of follow-up
. On this registry, six prospective trials with specific objectives have been built.
The i-RECORd project is designed as an observational prospective longitudinal trial involving 50 international, very-high-volume tertiary referral Centers with extensive experience in management of kidney cancer. Centers will be included in the project only if they will be able to certify at least to: 1) perform 150 partial and radical nephrectomy/year, or 2) to perform 80 ATs/year, or 3) to include 50 patients in WW/AS protocols/year.
The enrollment and follow-up periods will be 2 and 5 years, respectively. The estimate of patients' enrollment over the study period is 10'000 inclusions.
The 50 Centers finally enrolled in the i-RECORD project will be given the access to a web-based platform for data collection for 24 months from the starting date of the project.
A web-based e-form platform will be used for data collection.
Data collection
This observational study aims to obtain controlled, qualitative and quantitative, data of the enrolled patients through a web-based e-form platform. For all patients it will be asked to complete a data collection form specifically designed for this study, consisting of some subfolders:
- Anthropometric, pre-operative and comorbidity data (patient characteristics).
- Imaging data e and pre-operative tumor features (tumor characteristics).
- Intra-operative and post-operative data (treatment characteristics).
- Histopathological analysis (tumor histopathological characteristics).
- Patients follow-up variables (at 6, 12, 24 and 60 months from the treatment) (follow-up characteristics).
Decision Analysis Modeling
Beyond traditional descriptive and inferential statistical analyses, the i-RECORd project will provide a comprehensive overview of the current selection criteria for each type of management option by applying innovative statistical methods (Decision Analysis Modeling through discrete choice models) to determine the differential impact of all potential relevant variables on the choice of treatment. To do so, we will consider specific clinical scenarios (clinical clusters) made of the integration of patient characteristics (comorbidity score, performance status, age, gender, etc.), patient-reported outcomes measures (PROMs), tumors anatomical features (degree of complexity, clinical diameter, side, location within the kidney, involvement of renal sinus or collecting system, etc.), surgeon-related factors (surgical experience and background), hospital economic availabilities (i.e. open, laparoscopic, robotic surgery) and other country-specific socio-economical features in order to determine the impact of such variables on the final choice of treatment.
By applying the discrete choice model to the analysis of the prospective dataset, the i-RECORd project will overcome the current state of the art in the treatment of localized renal tumors as it will show how the choice of treatment is performed by the decision-maker (at a surgeon- and hospital-level) in each specific clinical cluster of patients, why that choice was performed according to a careful analysis of the personalized patient setting and whether that choice will influence the postoperative outcomes.
Adapted MAMS Registry
The i-RECORD will be designed adapting the innovative concept of multi-arm, multi-stage (MAMS) platform randomized trials (used, for instance, for the design of the Systemic Therapy in Advancing or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) Trial) to create a dynamic, observational registry evaluating simultaneously different management options in different patient- and/or tumor-related scenarios.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal tumor patiens | – | Procedure: Partial Nephrectomy (PN), Procedure: Radical Nephrectomy (RN), Procedure: Ablation therapy (AT), Diagnostic Test: Active Surveillance (AS)Patients with any renal tumor diagnosed with conventional imaging (computed tomography or magnetic resonance imaging) and undergoing to a clinical management in a hugh-volume center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population include patients with a radiological diagnosis of kidney tumor susceptible to surgical treatment (RN or PN) or AT or WW/AS will be eligible.
Key inclusion criteria (3 listed)
- Radiological diagnosis of renal tumor susceptible to active treatment or AS/WW.
- Age ≥18 years
- Informed consent signed
Key exclusion criteria (2 listed)
- Patient refuse to participate in clinical research.
- Urothelial renal carcinoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial Nephrectomy (PN)Conservative removal of kidney tumor. The procedure can be performed either with an open or laparoscopic or robotic approach. | Procedure or surgery | Renal tumor patiens |
| Radical Nephrectomy (RN)Surgical removal of the affected kidney. Adrenal removal can be performed according to surgeon choice and clinical characteristics of the renal tumor. The procedure can be performed either with an open or laparoscopic or robotic approach. | Procedure or surgery | Renal tumor patiens |
| Ablation therapy (AT)The procedure of tumor ablation performed with radiofrequency or cryoablation. The procedure can be performed either with a laparoscopic approach or percutaneous access. | Procedure or surgery | Renal tumor patiens |
| Active Surveillance (AS)Active surveillance is defined as the initial management including the monitoring of renal tumor size by serial imaging with delayed treatment in case of progression. | Diagnostic test | Renal tumor patiens |
Primary outcome
To test the effectiveness of partial nephrectomy for the treatment of localized renal tumors (T1-T2N0M0) with regards to recurrence-free survival and cardiovascular accidents and mortality in comparison to radical nephrectomy?
Time frame: Assesments of the outcome at 60 months from the surgical intervention. Time frame : 5 years
The preoperative characteristics of the patients will be specifically evaluated to calculate any heterogeneity between the two groups. In detail, anthropometric and comorbidity features, previous abdominal surgery, blood chemistry values, blood pressure, smoking habit, preoperative life expectancy, and frailty grade will be assessed. Imaging features of the tumor will be considered, including the characteristics necessary for the calculation of the PADUA, R.E.N.A.L., and Contact-Surface-Area scores. Patients with a node-positive or metastatic disease diagnosed with conventional imaging (CT scan/MRI) will be excluded. Intra-operative and post-operative outcomes will be evaluated. Histopathological features of the tumor will be assessed. Patients will be followed up with conventional imaging according to the International guidelines (ultrasound, CT, MRI). Serum creatinine, platelets and estimated glomerular function (eGFR), the onset of cardiovascular adverse events will be registered.
To test the effectiveness of robotic approach in partial nephrectomy to increase the "Trifecta" rate after nephron-sparing surgery in patients with T1-T2N0M0 renal tumors.
Time frame: Assesment of the "Trifecta" outcome will be performed at 12 months from the surgical intervention. Time frame: 1 year.
"Trifecta" rate is defined as 1) Absence of intraoperative and postoperative surgical complications; 2) absence of positive surgical margins or recurrences on tumor resection site during a 5-year follow-up; 3) Absence of clinically significant renal function loss at one year after surgery. Renal function will be evaluated using the estimated glomerular filtration rate (eGFR) in ml/min/1.73 m^2 using the CKD-EPI Creatinine Equation (2021). A clinically significant loss will be considered if >25% from eGFR at baseline. The "Trifecta" outcome will be evaluated one year from surgery.
3 secondary outcomes
To evaluate the differential impact of patients' comorbidities, tumors' complexity, surgeons' experience, country-related socio-cultural factors and hospital financial resources on the selection of the type of clinical management.
Time frame: Assesment will be done at the time of registering the type of surgery/clinical managing adopted. Time frame: <1 week from patients accrual..
To evaluate the impact of the antiaggregant and/or antiplatelet treatment at baseline and during partial nephrectomy on hemorrhagic complications.
Time frame: Outcome assesment will be done at 90 days from surgery. Time frame: 3 months
To assess in patients with antiaggregant and/or antiplatelet treatment at baseline any potential change of this therapy at the time of treatment associated with the absence of hemorrhagic complications.
Time frame: Outcome assesment will be done at 90 days from surgery. Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Results publication: PubMed 25616710Ljungberg B, Bensalah K, Canfield S, Dabestani S, Hofmann F, Hora M, Kuczyk MA, Lam T, Marconi L, Merseburger AS, Mulders P, Powles T, Staehler M, Volpe A, Bex A. EAU guidelines on renal cell carcinoma: 2014 update. Eur Urol. 2015 May;67(5):913-24. doi: 10.1016/j.eururo.2015.01.005. Epub 2015 Jan 21.
- Results publication: PubMed 27918777Global Burden of Disease Cancer Collaboration; Fitzmaurice C, Allen C, Barber RM, Barregard L, Bhutta ZA, Brenner H, Dicker DJ, Chimed-Orchir O, Dandona R, Dandona L, Fleming T, Forouzanfar MH, Hancock J, Hay RJ, Hunter-Merrill R, Huynh C, Hosgood HD, Johnson CO, Jonas JB, Khubchandani J, Kumar GA, Kutz M, Lan Q, Larson HJ, Liang X, Lim SS, Lopez AD, MacIntyre MF, Marczak L, Marquez N, Mokdad AH, Pinho C, Pourmalek F, Salomon JA, Sanabria JR, Sandar L, Sartorius B, Schwartz SM, Shackelford KA, Shibuya K, Stanaway J, Steiner C, Sun J, Takahashi K, Vollset SE, Vos T, Wagner JA, Wang H, Westerman R, Zeeb H, Zoeckler L, Abd-Allah F, Ahmed MB, Alabed S, Alam NK, Aldhahri SF, Alem G, Alemayohu MA, Ali R, Al-Raddadi R, Amare A, Amoako Y, Artaman A, Asayesh H, Atnafu N, Awasthi A, Saleem HB, Barac A, Bedi N, Bensenor I, Berhane A, Bernabe E, Betsu B, Binagwaho A, Boneya D, Campos-Nonato I, Castaneda-Orjuela C, Catala-Lopez F, Chiang P, Chibueze C, Chitheer A, Choi JY, Cowie B, Damtew S, das Neves J, Dey S, Dharmaratne S, Dhillon P, Ding E, Driscoll T, Ekwueme D, Endries AY, Farvid M, Farzadfar F, Fernandes J, Fischer F, G/Hiwot TT, Gebru A, Gopalani S, Hailu A, Horino M, Horita N, Husseini A, Huybrechts I, Inoue M, Islami F, Jakovljevic M, James S, Javanbakht M, Jee SH, Kasaeian A, Kedir MS, Khader YS, Khang YH, Kim D, Leigh J, Linn S, Lunevicius R, El Razek HMA, Malekzadeh R, Malta DC, Marcenes W, Markos D, Melaku YA, Meles KG, Mendoza W, Mengiste DT, Meretoja TJ, Miller TR, Mohammad KA, Mohammadi A, Mohammed S, Moradi-Lakeh M, Nagel G, Nand D, Le Nguyen Q, Nolte S, Ogbo FA, Oladimeji KE, Oren E, Pa M, Park EK, Pereira DM, Plass D, Qorbani M, Radfar A, Rafay A, Rahman M, Rana SM, Soreide K, Satpathy M, Sawhney M, Sepanlou SG, Shaikh MA, She J, Shiue I, Shore HR, Shrime MG, So S, Soneji S, Stathopoulou V, Stroumpoulis K, Sufiyan MB, Sykes BL, Tabares-Seisdedos R, Tadese F, Tedla BA, Tessema GA, Thakur JS, Tran BX, Ukwaja KN, Uzochukwu BSC, Vlassov VV, Weiderpass E, Wubshet Terefe M, Yebyo HG, Yimam HH, Yonemoto N, Younis MZ, Yu C, Zaidi Z, Zaki MES, Zenebe ZM, Murray CJL, Naghavi M. Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-years for 32 Cancer Groups, 1990 to 2015: A Systematic Analysis for the Global Burden of Disease Study. JAMA Oncol. 2017 Apr 1;3(4):524-548. doi: 10.1001/jamaoncol.2016.5688.
- Results publication: PubMed 28479239Campbell S, Uzzo RG, Allaf ME, Bass EB, Cadeddu JA, Chang A, Clark PE, Davis BJ, Derweesh IH, Giambarresi L, Gervais DA, Hu SL, Lane BR, Leibovich BC, Pierorazio PM. Renal Mass and Localized Renal Cancer: AUA Guideline. J Urol. 2017 Sep;198(3):520-529. doi: 10.1016/j.juro.2017.04.100. Epub 2017 May 4.
- Results publication: PubMed 25403213Stewart SB, Thompson RH, Psutka SP, Cheville JC, Lohse CM, Boorjian SA, Leibovich BC. Evaluation of the National Comprehensive Cancer Network and American Urological Association renal cell carcinoma surveillance guidelines. J Clin Oncol. 2014 Dec 20;32(36):4059-65. doi: 10.1200/JCO.2014.56.5416. Epub 2014 Nov 17.
- Results publication: PubMed 28596261Motzer RJ, Jonasch E, Agarwal N, Bhayani S, Bro WP, Chang SS, Choueiri TK, Costello BA, Derweesh IH, Fishman M, Gallagher TH, Gore JL, Hancock SL, Harrison MR, Kim W, Kyriakopoulos C, LaGrange C, Lam ET, Lau C, Michaelson MD, Olencki T, Pierorazio PM, Plimack ER, Redman BG, Shuch B, Somer B, Sonpavde G, Sosman J, Dwyer M, Kumar R. Kidney Cancer, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2017 Jun;15(6):804-834. doi: 10.6004/jnccn.2017.0100.
- Results publication: PubMed 25703575Volpe A, Blute ML, Ficarra V, Gill IS, Kutikov A, Porpiglia F, Rogers C, Touijer KA, Van Poppel H, Thompson RH. Renal Ischemia and Function After Partial Nephrectomy: A Collaborative Review of the Literature. Eur Urol. 2015 Jul;68(1):61-74. doi: 10.1016/j.eururo.2015.01.025. Epub 2015 Feb 20.
- Results publication: PubMed 28095147Finelli A, Ismaila N, Bro B, Durack J, Eggener S, Evans A, Gill I, Graham D, Huang W, Jewett MA, Latcha S, Lowrance W, Rosner M, Shayegan B, Thompson RH, Uzzo R, Russo P. Management of Small Renal Masses: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2017 Feb 20;35(6):668-680. doi: 10.1200/JCO.2016.69.9645. Epub 2017 Jan 17.
- Results publication: PubMed 27692535Larcher A, Sun M, Dell'Oglio P, Trudeau V, Boehm K, Schiffmann J, Tian Z, Fossati N, Capitanio U, Briganti A, Montorsi F, Karakiewicz P. Mortality, morbidity and healthcare expenditures after local tumour ablation or partial nephrectomy for T1A kidney cancer. Eur J Surg Oncol. 2017 Apr;43(4):815-822. doi: 10.1016/j.ejso.2016.08.023. Epub 2016 Sep 17.
- Results publication: PubMed 26206408Larcher A, Fossati N, Tian Z, Boehm K, Meskawi M, Valdivieso R, Trudeau V, Dell'Oglio P, Buffi N, Montorsi F, Guazzoni G, Sun M, Karakiewicz PI. Prediction of Complications Following Partial Nephrectomy: Implications for Ablative Techniques Candidates. Eur Urol. 2016 Apr;69(4):676-682. doi: 10.1016/j.eururo.2015.07.003. Epub 2015 Jul 21.
- Results publication: PubMed 27988238Kim SP, Campbell SC, Gill I, Lane BR, Van Poppel H, Smaldone MC, Volpe A, Kutikov A. Collaborative Review of Risk Benefit Trade-offs Between Partial and Radical Nephrectomy in the Management of Anatomically Complex Renal Masses. Eur Urol. 2017 Jul;72(1):64-75. doi: 10.1016/j.eururo.2016.11.038. Epub 2016 Dec 14.
- Results publication: PubMed 28483780Patel HD, Pierorazio PM, Johnson MH, Sharma R, Iyoha E, Allaf ME, Bass EB, Sozio SM. Renal Functional Outcomes after Surgery, Ablation, and Active Surveillance of Localized Renal Tumors: A Systematic Review and Meta-Analysis. Clin J Am Soc Nephrol. 2017 Jul 7;12(7):1057-1069. doi: 10.2215/CJN.11941116. Epub 2017 May 8.
- Results publication: PubMed 30653796Mari A, Campi R, Schiavina R, Amparore D, Antonelli A, Artibani W, Barale M, Bertini R, Borghesi M, Bove P, Brunocilla E, Capitanio U, Da Pozzo L, Daja J, Gontero P, Larcher A, Li Marzi V, Longo N, Mirone V, Montanari E, Pisano F, Porpiglia F, Simeone C, Siracusano S, Tellini R, Trombetta C, Volpe A, Ficarra V, Carini M, Minervini A; Collaborators. Nomogram for predicting the likelihood of postoperative surgical complications in patients treated with partial nephrectomy: a prospective multicentre observational study (the RECORd 2 project). BJU Int. 2019 Jul;124(1):93-102. doi: 10.1111/bju.14680. Epub 2019 Feb 12.
- Individual participant dataSharing planned: Yes. The study protocol has been shared on the web platform of the i-RECORd project. The study has been shared with a specific Twitter page for the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Minervini, Prof. principal investigator
Dipartimento di Medicina Clinica e Sperimentale Via o Piazza Largo Brambilla 3 - 50134 Firenze (Italy)
37 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Cancer, run by Azienda Ospedaliero-Universitaria Careggi at 37 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Italy, United States, Belgium, Poland, Spain and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Carini, Prof. (055 794 6351, carini@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To test the effectiveness of partial nephrectomy for the treatment of localized renal tumors (T1-T2N0M0) with regards to recurrence-free survival and cardiovascular accidents and mortality in comparison to radical nephrectomy? (time frame: Assesments of the outcome at 60 months from the surgical intervention. Time frame : 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05363657, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.