Renal Cell CarcinomaBRCNCT05785052
Biomarkers of Renal Cancer
An observational study of Renal Cell Carcinoma and Tumor, Solid, run by Biorek S.R.L. at 4 sites in 2 countries.
Trial summary
The aim of the present study is the identification, in liquid biopsies, of a new molecular panel able to discriminate renal cancer patients from controls, to discriminate patients with a malignant lesion from those with a benign mass, to determine aggressiveness of RCC, and to differentiate the most common… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Tumor, Solid, Oncocytoma
- How many people
- 1,000 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 11 Jun 2019to Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Cases: patients diagnosed with a first episode of renal mass. Control subjects: living kidney donor or patient with urological functional diseases.
Who may be able to join
- Men and women over 18 years of age
- Diagnosis of first episode of renal mass
- Caucasian race
- Signed, informed consent
- Men and women over 18 years of age
- Caucasian race
- Living kidney donor or patient with urological functional diseases (e.g. kidney stones, benign prostate hypertrophy, etc..)
- Signed, informed consent
Who cannot join
- Any other concomitant cancer or history of active cancer in the last 5 years
- Oncological genetic syndrome
- Previous history of renal tumour
- Urothelial cancer
- End-stage renal disease on hemodialysis
- Bilateral renal cell carcinoma
Show all 9Show fewer
- History of active cancer in the last 5 years
- Oncological genetic syndrome
- End-stage renal disease on hemodialysis or peritoneal dialysis
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Italy3 sites, 3 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Careggi
Florence, 50139
Andrea Mari
- Recruiting
IRCCS San Raffaele
Milan, 20132
Francesco Montorsi
- Recruiting
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano, 10043
Daniele Amparore
Spain1 site, 1 recruiting
- Recruiting
Fundació Puigvert
Barcelona, 08025
Angelo Territo
About this study
The aim of the present study is the identification, in liquid biopsies, of a new molecular panel able to discriminate renal cancer patients from controls, to discriminate patients with a malignant lesion from those with a benign mass, to determine aggressiveness of RCC, and to differentiate the most common histological subtypes of RCC (clear cell, papillary 1, papillary 2, and chromophobe).
This new molecular panel will be combined with clinical parameters to provide a screening test and to improve the accuracy and specificity of diagnosis, prognosis, and histological classification of renal cancer.
Read the detailed description
The study is a translational one of the duration of 7 years and it is composed by a retrospective and a prospective phases.
- Retrospective phase: Retrospective analysis of liquid and solid biopsies of patients diagnosed with a first episode of renal mass (of any histological subtype, such as clear cell RCC, type 1 and type 2 papillary RCC, chromophobe RCC, oncocytoma, and angiomyolipoma) and treated with radical or partial nephrectomy, in order to identify specific biomarkers for the screening, diagnosis, prognosis, and histological classification of renal cancer. Patients with a first episode of renal mass whose plasma, urine, tumor and matched normal kidney tissue, and PBMC have been collected and stored in a biobank since 2011, will be stratified in different groups according to (i) the nature of renal mass (benign or malignant), (ii) the aggressiveness of renal cancer (indolent kidney cancer or aggressive kidney cancer), and (iii) the presence or absence of clinical metastasis; (iv) specific histotype of renal mass (e.g., clear cell RCC, type 1 and type 2 papillary RCC, chromophobe RCC, oncocytoma, and angiomyolipoma). The same type of biological samples mentioned above from patients affected by urological functional diseases (such as kidney stones or benign prostate hypertrophy) have been collected and stored in a biobank between 2014 and 2018 and will be also analyzed as controls. The samples will be fractionated and subjected to different analysis, such as the detection of nucleic acids (DNA and RNA), and proteins. These macromolecules will be purified and analyzed by employing methods such as real time PCR, microarrays, sequencing, ELISA assays, or mass spectrometry.
- Prospective phase and multicenter trial:
Validation of the biomarker panel in a wider cohort of patients affected by renal mass.
An ideal tumor marker is easily detected and dosed, is sensitive and specific and its clinical significance is easy to deduce. To confirm the results obtained in archived samples and validate a panel of biomarkers to be translate in the clinical practice, it will be collected whole blood, plasma and urine samples from a validation cohort of patients.
It will enrolled patients affected by renal masses (e.g., clear cell RCC, type 1 and type 2 papillary RCC, chromophobe RCC, oncocytoma, and angiomyolipoma), who will undergo radical or partial nephrectomy, and controls (patients affected by urological functional diseases, such as kidney stones or benign prostate hypertrophy) with a ratio of 2:1 in all centers included.
For each patients, clinical data will be collected, creating a dataset with the same variables used in the discovery cohort.
The aim of this prospective phase will be to confirm that the identified molecules can improve the management of patients with RCC at all the stages of clinical decision-making, in particular for the screening, diagnosis, prognosis, and histological classification of RCC.
- Conditions
- Renal Cell Carcinoma, Tumor, Solid, Oncocytoma, Angiomyolipoma
- Keywords
- Biomarkers, Urology, Renal Cell Carcinoma, Molecular Biomarkers, Oncology
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasms, Adenoma, Oxyphilic, Angiomyolipoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Renal-mass patients | Patients diagnosed with a first episode of renal mass attending the urology department. | |
| Control subjects | Patients affected by urological functional diseases or living kidney donor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening
Identification of biomarkers able to predict the presence of a renal mass, defined as a mass either benign or malignant recorded at axial imaging examination (either CT or MRI).
Measured: Analysis of biological samples collected before surgery
Diagnosis
Identification of biomarkers able to predict the presence of a Renal Cell Carcinoma, defined as a renal malignancy
Measured: Analysis of biological samples collected before surgery
Prognosis
Identification of biomarkers able to predict the presence of an aggressive Renal Cell Carcinoma
Measured: Analysis of biological samples collected before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start11 Jun 2019
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CarcinomaStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biorek S.R.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francesco Montorsi, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785052
- Sponsor's protocol ID
- BRC
- Acronym
- BRC
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Capitanio U, Terrone C, Antonelli A, Minervini A, Volpe A, Furlan M, Matloob R, Regis F, Fiori C, Porpiglia F, Di Trapani E, Zacchero M, Serni S, Salonia A, Carini M, Simeone C, Montorsi F, Bertini R. Nephron-sparing techniques independently decrease the risk of cardiovascular events relative to radical nephrectomy in patients with a T1a-T1b renal mass and normal preoperative renal function. Eur Urol. 2015 Apr;67(4):683-9. doi: 10.1016/j.eururo.2014.09.027. Epub 2014 Oct 3.
PubMed 25282367Chanudet E, Wozniak MB, Bouaoun L, Byrnes G, Mukeriya A, Zaridze D, Brennan P, Muller DC, Scelo G. Large-scale genome-wide screening of circulating microRNAs in clear cell renal cell carcinoma reveals specific signatures in late-stage disease. Int J Cancer. 2017 Nov 1;141(9):1730-1740. doi: 10.1002/ijc.30845. Epub 2017 Jul 7.
PubMed 28639257Chow WH, Dong LM, Devesa SS. Epidemiology and risk factors for kidney cancer. Nat Rev Urol. 2010 May;7(5):245-57. doi: 10.1038/nrurol.2010.46.
PubMed 20448658Cumberbatch MG, Rota M, Catto JW, La Vecchia C. The Role of Tobacco Smoke in Bladder and Kidney Carcinogenesis: A Comparison of Exposures and Meta-analysis of Incidence and Mortality Risks. Eur Urol. 2016 Sep;70(3):458-66. doi: 10.1016/j.eururo.2015.06.042. Epub 2015 Jul 3.
PubMed 26149669Fedorko M, Stanik M, Iliev R, Redova-Lojova M, Machackova T, Svoboda M, Pacik D, Dolezel J, Slaby O. Combination of MiR-378 and MiR-210 Serum Levels Enables Sensitive Detection of Renal Cell Carcinoma. Int J Mol Sci. 2015 Sep 29;16(10):23382-9. doi: 10.3390/ijms161023382.
PubMed 26426010Gatto F, Maruzzo M, Magro C, Basso U, Nielsen J. Prognostic Value of Plasma and Urine Glycosaminoglycan Scores in Clear Cell Renal Cell Carcinoma. Front Oncol. 2016 Nov 24;6:253. doi: 10.3389/fonc.2016.00253. eCollection 2016.
PubMed 27933273Hauser S, Wulfken LM, Holdenrieder S, Moritz R, Ohlmann CH, Jung V, Becker F, Herrmann E, Walgenbach-Brunagel G, von Ruecker A, Muller SC, Ellinger J. Analysis of serum microRNAs (miR-26a-2*, miR-191, miR-337-3p and miR-378) as potential biomarkers in renal cell carcinoma. Cancer Epidemiol. 2012 Aug;36(4):391-4. doi: 10.1016/j.canep.2012.04.001. Epub 2012 Apr 26.
PubMed 22542158Heidenreich A, Ravery V; European Society of Oncological Urology. Preoperative imaging in renal cell cancer. World J Urol. 2004 Nov;22(5):307-15. doi: 10.1007/s00345-004-0411-2. Epub 2004 Jul 30.
PubMed 15290202Hollingsworth JM, Miller DC, Daignault S, Hollenbeck BK. Five-year survival after surgical treatment for kidney cancer: a population-based competing risk analysis. Cancer. 2007 May 1;109(9):1763-8. doi: 10.1002/cncr.22600.
PubMed 17351954Iwamoto H, Kanda Y, Sejima T, Osaki M, Okada F, Takenaka A. Serum miR-210 as a potential biomarker of early clear cell renal cell carcinoma. Int J Oncol. 2014 Jan;44(1):53-8. doi: 10.3892/ijo.2013.2169. Epub 2013 Nov 7.
PubMed 24212760Kutikov A, Uzzo RG. The R.E.N.A.L. nephrometry score: a comprehensive standardized system for quantitating renal tumor size, location and depth. J Urol. 2009 Sep;182(3):844-53. doi: 10.1016/j.juro.2009.05.035. Epub 2009 Jul 17.
PubMed 19616235Linehan WM, Pinto PA, Srinivasan R, Merino M, Choyke P, Choyke L, Coleman J, Toro J, Glenn G, Vocke C, Zbar B, Schmidt LS, Bottaro D, Neckers L. Identification of the genes for kidney cancer: opportunity for disease-specific targeted therapeutics. Clin Cancer Res. 2007 Jan 15;13(2 Pt 2):671s-679s. doi: 10.1158/1078-0432.CCR-06-1870.
PubMed 17255292Ljungberg 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 25616710Morrissey JJ, Mellnick VM, Luo J, Siegel MJ, Figenshau RS, Bhayani S, Kharasch ED. Evaluation of Urine Aquaporin-1 and Perilipin-2 Concentrations as Biomarkers to Screen for Renal Cell Carcinoma: A Prospective Cohort Study. JAMA Oncol. 2015 May;1(2):204-12. doi: 10.1001/jamaoncol.2015.0213.
PubMed 26181025Morrissey JJ, Mobley J, Figenshau RS, Vetter J, Bhayani S, Kharasch ED. Urine aquaporin 1 and perilipin 2 differentiate renal carcinomas from other imaged renal masses and bladder and prostate cancer. Mayo Clin Proc. 2015 Jan;90(1):35-42. doi: 10.1016/j.mayocp.2014.10.005.
PubMed 25572193
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Renal Cancer
- ClinicalTrials.gov ID
- NCT05785052
- Acronym / sponsor ID
- BRC / BRC
- Conditions
- Renal Cell Carcinoma, Tumor, Solid, Oncocytoma, Angiomyolipoma
- Keywords
- Biomarkers, Urology, Renal Cell Carcinoma, Molecular Biomarkers, Oncology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Biorek S.R.L.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 27 Mar 2023 (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.
The aim of the present study is the identification, in liquid biopsies, of a new molecular panel able to discriminate renal cancer patients from controls, to discriminate patients with a malignant lesion from those with a benign mass, to determine aggressiveness of RCC, and to differentiate the most common histological subtypes of RCC (clear cell, papillary 1, papillary 2, and chromophobe).
This new molecular panel will be combined with clinical parameters to provide a screening test and to improve the accuracy and specificity of diagnosis, prognosis, and histological classification of renal cancer.
Detailed description
The study is a translational one of the duration of 7 years and it is composed by a retrospective and a prospective phases.
- Retrospective phase: Retrospective analysis of liquid and solid biopsies of patients diagnosed with a first episode of renal mass (of any histological subtype, such as clear cell RCC, type 1 and type 2 papillary RCC, chromophobe RCC, oncocytoma, and angiomyolipoma) and treated with radical or partial nephrectomy, in order to identify specific biomarkers for the screening, diagnosis, prognosis, and histological classification of renal cancer. Patients with a first episode of renal mass whose plasma, urine, tumor and matched normal kidney tissue, and PBMC have been collected and stored in a biobank since 2011, will be stratified in different groups according to (i) the nature of renal mass (benign or malignant), (ii) the aggressiveness of renal cancer (indolent kidney cancer or aggressive kidney cancer), and (iii) the presence or absence of clinical metastasis; (iv) specific histotype of renal mass (e.g., clear cell RCC, type 1 and type 2 papillary RCC, chromophobe RCC, oncocytoma, and angiomyolipoma). The same type of biological samples mentioned above from patients affected by urological functional diseases (such as kidney stones or benign prostate hypertrophy) have been collected and stored in a biobank between 2014 and 2018 and will be also analyzed as controls. The samples will be fractionated and subjected to different analysis, such as the detection of nucleic acids (DNA and RNA), and proteins. These macromolecules will be purified and analyzed by employing methods such as real time PCR, microarrays, sequencing, ELISA assays, or mass spectrometry.
- Prospective phase and multicenter trial:
Validation of the biomarker panel in a wider cohort of patients affected by renal mass.
An ideal tumor marker is easily detected and dosed, is sensitive and specific and its clinical significance is easy to deduce. To confirm the results obtained in archived samples and validate a panel of biomarkers to be translate in the clinical practice, it will be collected whole blood, plasma and urine samples from a validation cohort of patients.
It will enrolled patients affected by renal masses (e.g., clear cell RCC, type 1 and type 2 papillary RCC, chromophobe RCC, oncocytoma, and angiomyolipoma), who will undergo radical or partial nephrectomy, and controls (patients affected by urological functional diseases, such as kidney stones or benign prostate hypertrophy) with a ratio of 2:1 in all centers included.
For each patients, clinical data will be collected, creating a dataset with the same variables used in the discovery cohort.
The aim of this prospective phase will be to confirm that the identified molecules can improve the management of patients with RCC at all the stages of clinical decision-making, in particular for the screening, diagnosis, prognosis, and histological classification of RCC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal-mass patients | – | –Patients diagnosed with a first episode of renal mass attending the urology department. |
| Control subjects | – | –Patients affected by urological functional diseases or living kidney donor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cases: patients diagnosed with a first episode of renal mass. Control subjects: living kidney donor or patient with urological functional diseases.
Key inclusion criteria (8 listed)
- Men and women over 18 years of age
- Diagnosis of first episode of renal mass
- Caucasian race
- Signed, informed consent
- Men and women over 18 years of age
Key exclusion criteria (9 listed)
- Any other concomitant cancer or history of active cancer in the last 5 years
- Oncological genetic syndrome
- Previous history of renal tumour
- Urothelial cancer
- End-stage renal disease on hemodialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Screening
Time frame: Analysis of biological samples collected before surgery
Identification of biomarkers able to predict the presence of a renal mass, defined as a mass either benign or malignant recorded at axial imaging examination (either CT or MRI).
Diagnosis
Time frame: Analysis of biological samples collected before surgery
Identification of biomarkers able to predict the presence of a Renal Cell Carcinoma, defined as a renal malignancy
Prognosis
Time frame: Analysis of biological samples collected before surgery
Identification of biomarkers able to predict the presence of an aggressive Renal Cell Carcinoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Background: PubMed 25282367Capitanio U, Terrone C, Antonelli A, Minervini A, Volpe A, Furlan M, Matloob R, Regis F, Fiori C, Porpiglia F, Di Trapani E, Zacchero M, Serni S, Salonia A, Carini M, Simeone C, Montorsi F, Bertini R. Nephron-sparing techniques independently decrease the risk of cardiovascular events relative to radical nephrectomy in patients with a T1a-T1b renal mass and normal preoperative renal function. Eur Urol. 2015 Apr;67(4):683-9. doi: 10.1016/j.eururo.2014.09.027. Epub 2014 Oct 3.
- Background: PubMed 28639257Chanudet E, Wozniak MB, Bouaoun L, Byrnes G, Mukeriya A, Zaridze D, Brennan P, Muller DC, Scelo G. Large-scale genome-wide screening of circulating microRNAs in clear cell renal cell carcinoma reveals specific signatures in late-stage disease. Int J Cancer. 2017 Nov 1;141(9):1730-1740. doi: 10.1002/ijc.30845. Epub 2017 Jul 7.
- Background: PubMed 20448658Chow WH, Dong LM, Devesa SS. Epidemiology and risk factors for kidney cancer. Nat Rev Urol. 2010 May;7(5):245-57. doi: 10.1038/nrurol.2010.46.
- Background: PubMed 26149669Cumberbatch MG, Rota M, Catto JW, La Vecchia C. The Role of Tobacco Smoke in Bladder and Kidney Carcinogenesis: A Comparison of Exposures and Meta-analysis of Incidence and Mortality Risks. Eur Urol. 2016 Sep;70(3):458-66. doi: 10.1016/j.eururo.2015.06.042. Epub 2015 Jul 3.
- Background: PubMed 26426010Fedorko M, Stanik M, Iliev R, Redova-Lojova M, Machackova T, Svoboda M, Pacik D, Dolezel J, Slaby O. Combination of MiR-378 and MiR-210 Serum Levels Enables Sensitive Detection of Renal Cell Carcinoma. Int J Mol Sci. 2015 Sep 29;16(10):23382-9. doi: 10.3390/ijms161023382.
- Background: PubMed 27933273Gatto F, Maruzzo M, Magro C, Basso U, Nielsen J. Prognostic Value of Plasma and Urine Glycosaminoglycan Scores in Clear Cell Renal Cell Carcinoma. Front Oncol. 2016 Nov 24;6:253. doi: 10.3389/fonc.2016.00253. eCollection 2016.
- Background: PubMed 22542158Hauser S, Wulfken LM, Holdenrieder S, Moritz R, Ohlmann CH, Jung V, Becker F, Herrmann E, Walgenbach-Brunagel G, von Ruecker A, Muller SC, Ellinger J. Analysis of serum microRNAs (miR-26a-2*, miR-191, miR-337-3p and miR-378) as potential biomarkers in renal cell carcinoma. Cancer Epidemiol. 2012 Aug;36(4):391-4. doi: 10.1016/j.canep.2012.04.001. Epub 2012 Apr 26.
- Background: PubMed 15290202Heidenreich A, Ravery V; European Society of Oncological Urology. Preoperative imaging in renal cell cancer. World J Urol. 2004 Nov;22(5):307-15. doi: 10.1007/s00345-004-0411-2. Epub 2004 Jul 30.
- Background: PubMed 17351954Hollingsworth JM, Miller DC, Daignault S, Hollenbeck BK. Five-year survival after surgical treatment for kidney cancer: a population-based competing risk analysis. Cancer. 2007 May 1;109(9):1763-8. doi: 10.1002/cncr.22600.
- Background: PubMed 24212760Iwamoto H, Kanda Y, Sejima T, Osaki M, Okada F, Takenaka A. Serum miR-210 as a potential biomarker of early clear cell renal cell carcinoma. Int J Oncol. 2014 Jan;44(1):53-8. doi: 10.3892/ijo.2013.2169. Epub 2013 Nov 7.
- Background: PubMed 19616235Kutikov A, Uzzo RG. The R.E.N.A.L. nephrometry score: a comprehensive standardized system for quantitating renal tumor size, location and depth. J Urol. 2009 Sep;182(3):844-53. doi: 10.1016/j.juro.2009.05.035. Epub 2009 Jul 17.
- Background: PubMed 17255292Linehan WM, Pinto PA, Srinivasan R, Merino M, Choyke P, Choyke L, Coleman J, Toro J, Glenn G, Vocke C, Zbar B, Schmidt LS, Bottaro D, Neckers L. Identification of the genes for kidney cancer: opportunity for disease-specific targeted therapeutics. Clin Cancer Res. 2007 Jan 15;13(2 Pt 2):671s-679s. doi: 10.1158/1078-0432.CCR-06-1870.
Related trials for Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
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. This study is not recruiting at the moment.
Francesco Montorsi principal investigator
IRCCS San Raffaele
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma and Tumor, Solid, run by Biorek S.R.L. at 4 sites in 2 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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Trevisani (0226435857 ext. 0039, francesco.trevisani@biorek.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening (time frame: Analysis of biological samples collected before surgery). The study lists 3 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 NCT05785052, which also lists 25 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 27 Mar 2023.