Kidney CancerRUPTURENCT07065825
Tumor Rupture During Robotic Partial Nephrectomy
An observational study of Kidney Cancer and Renal Neoplasms, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial summary
The RUPTURE Project is a multi-center observational study aiming to understand tumor rupture during robotic partial nephrectomy (RAPN), a minimally invasive surgery used to treat kidney tumors. Tumor rupture-an unintended break of the tumor capsule during surgery-occurs in about 10-15% of cases but is poorly studied. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Cancer, Renal Neoplasms
- What is being tested?
- robot-assisted partial nephrectomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2025to Dec 2030
- How long will I take part?
- 5 Years
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of interest comprises all patients undergoing RAPN for renal mass.
Who may be able to join
- Patients who experienced tumor rupture during RAPN (referred to an unintended breach of the tumor capsule with or without spillage of malignant tissue during tumor resection)
- Patients who provide informed consent to participate
- Patients from 18 to 80 years of age.
Who cannot join
- Patients undergoing radical nephrectomy or other nephron-sparing procedures.
- Patients undergoing partial nephrectomy with other approaches (open, pure laparoscopic)
- Patients with multiple ipsilateral tumors
- Patients diagnosed with genetic abnormalities that increase the likelihood of developing renal cell carcinoma.
- Patients who deny consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
AOUI Verona
Verona, 37120
Riccardo Giuseppe Bertolo, MD, PhD, +39 045 812 1111, riccardogiuseppe.bertolo@univr.it
About this study
Official title: A Retro-Prospective Observational Study on Causes, Characteristics, Intraoperative Management and Impact on Prognosis
The RUPTURE Project is a multi-center observational study aiming to understand tumor rupture during robotic partial nephrectomy (RAPN), a minimally invasive surgery used to treat kidney tumors. Tumor rupture-an unintended break of the tumor capsule during surgery-occurs in about 10-15% of cases but is poorly studied. This event may increase the risk of cancer recurrence or spread, but its true impact is still unclear.
The study includes adult patients who experienced a tumor rupture during RAPN. Researchers will collect data on patient and tumor characteristics, surgical techniques, how the rupture occurred and was managed, and long-term outcomes. Follow-up visits will monitor for recurrence, metastases, and survival for up to five years. No experimental treatments or extra procedures are involved; only standard care is followed.
By analyzing at least 100 cases from various hospitals, the study hopes to clarify whether tumor rupture affects prognosis and to identify risk factors and best practices for managing it. This could help improve patient safety, surgical strategies, and future clinical guidelines. All data are handled confidentially, and participation is voluntary.
Read the detailed description
Background Robotic-assisted partial nephrectomy (RAPN) is a common, minimally invasive surgery used to remove kidney tumors while preserving healthy kidney tissue. While generally safe and effective, a complication called tumor rupture may occasionally occur. This means the tumor capsule (its outer layer) breaks during surgery, sometimes causing cancer cells to spill into the body. Although reported in up to 15% of surgeries, tumor rupture is not well understood, and its impact on long-term cancer outcomes remains unclear.
Purpose of the Study
This study, called the RUPTURE Project, aims to better understand tumor rupture during RAPN by answering key questions:
Does tumor rupture affect cancer recurrence or survival?
What causes it?
How can it be effectively managed during surgery?
How the Study Works This is a retro-prospective observational study, meaning it collects and analyzes both past and future cases of tumor rupture during RAPN. It involves multiple hospitals and surgical centers.
Who Can Participate? The study includes adult patients (18-80 years) who experienced a tumor rupture during RAPN and agree to participate. It excludes patients who had a radical nephrectomy (complete kidney removal), underwent open or laparoscopic surgery instead of robotic surgery, or had other complex medical conditions affecting the kidneys.
What Data Is Collected?
No additional procedures are required beyond standard clinical care. The study gathers information about:
Patient characteristics (age, health status, kidney function)
Tumor characteristics (size, location, type)
Surgical details (how the rupture occurred, surgical tools used, and how the situation was managed)
Pathological analysis (tumor grade, stage, margins)
Follow-up outcomes, including:
Local recurrence of the tumor
Spread (metastasis) to other parts of the body
Cancer-related and all-cause survival over a 5-year period
Why This Study Matters
Currently, there are no standardized guidelines for managing tumor rupture during kidney surgery. The RUPTURE Project will provide essential information to help:
Predict when and why ruptures occur
Guide surgeons on best practices during rupture events
Understand the long-term impact on patient health
Impact on Patients and Health Providers
The results of this study could lead to:
Safer surgeries with fewer complications
Improved guidelines for managing tumor rupture
Better information for patients facing kidney surgery
Potential changes in how surgeons plan and respond to complications
Study Duration The study will collect data over 2 years and follow up with patients for at least 5 years. A total of 100 or more cases of tumor rupture are expected to be analyzed across multiple centers.
Ethical and Privacy Considerations Participation is voluntary, and all patient data is handled confidentially, in compliance with European and Italian privacy laws (GDPR and national regulations). No experimental treatments or changes to care are made-this is strictly an observational study.
- Conditions
- Kidney Cancer, Renal Neoplasms
- Being tested
- robot-assisted partial nephrectomy
- Keywords
- robotic, robotic surgery, partial nephrectomy, tumor rupture, tumour rupture, tumor resection, kidney cancer, small renal mass, robotic partial nephrectomy, robot-assisted partial nephrectomy
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robot-assisted partial nephrectomyProcedure or surgery
Also called robotic partial nephrectomy, RAPN, RPN
Robotic-Assisted Partial Nephrectomy (RAPN) is a minimally invasive surgical procedure performed with the help of a robotic system to remove a kidney tumor while preserving as much healthy kidney tissue as possible. It is commonly used to treat small to medium-sized kidney tumors. Thanks to the precision of robotic technology, RAPN offers faster recovery, less postoperative pain, and fewer complications compared to traditional open surgery.
| Study group | Role | What they receive |
|---|---|---|
| Patients who experienced tumor rupture during robotic partial nephrectomy | Patients who experienced tumor rupture during RAPN (referred to an unintended breach of the tumor capsule with or without spillage of malignant tissue during tumor resection) Receives: Procedure: robot-assisted partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative incidence of recurrences
cumulative incidence of tumor local recurrences (at surgery site)
Measured: From date of enrolment until the date of first documented event, assessed up to 60 months
Cumulative incidence of Metastases
cumulative incidence of tumor distant metastases
Measured: From date of enrolment until the date of first documented event, assessed up to 60 months
Cumulative incidence of Cancer-related Deaths
Cumulative incidence of cancer-related deaths (deaths due to the disease). This will be evaluated through cancer-specific survival (CSS)
Measured: From date of enrolment until the date of first documented event, assessed up to 60 months
Cumulative incidence of All-cause Deaths
Cumulative incidence of non-cancer-related deaths (deaths due to other cause) disease). This will be evaluated through overall survival (OS)
Measured: From date of enrolment until the date of first documented event, assessed up to 60 months
Secondary outcomes (4)
Timing of tumor rupture
To evaluate the timing of tumor rupture (if it occurs during tumor isolation, at the early of tumor resection, almost at completion of the resection, at tumor grabbing for bagging).
Measured: During surgery
type of tumor rupture
Will evaluate the type of rupture, focal vs. gross; with vs. without spillage of tumor cells
Measured: During surgery
Cause of rupture
Will evaluate the cause of rupture (if it is due to the surgeon's move vs. an assistant's action)
Measured: During surgery
Surgical instrument causing the rupture
Will evaluate which robotic instruments, or which assistant's instrument did cause the tumor rupture
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Investigación Hospital IMED Valencia, Valencia, Spain, Hospital Clinic of Barcelona, The Cleveland Clinic, Fundacio Puigvert, San Raffaele University Hospital, Italy, Guy's and St Thomas' NHS Foundation Trust, University Hospital, Bordeaux, Fox Chase Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Azienda Ospedaliero-Universitaria Careggi, San Luigi Gonzaga Hospital, Changhai Hospital, St. George's Hospital, London, Frimley Health NHS Foundation Trust, Icahn School of Medicine at Mount Sinai, Rennes University Hospital, University of Illinois at Chicago, University of California, San Diego, Hospital da Luz Lisboa, Portugal, Swedish Medical Center, IRCCS Azienda Ospedaliero-Universitaria di Bologna, St. Antonius Hospital Gronau, Regina Elena Cancer Institute, Pitié-Salpêtrière Hospital, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Onze Lieve Vrouwziekenhuis Aalst, Hannover Medical School, Royal Free and University College Medical School, Università degli Studi del Piemonte Orientale Amedeo Avogadro, Memorial Sloan Kettering Cancer Center, The Netherlands Cancer Institute, A.O.U. Città della Salute e della Scienza - Molinette Hospital, University Medical Centre Ljubljana
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065825
- Sponsor's protocol ID
- 674CET
- Acronym
- RUPTURE
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu P, Zhang S, Cao B, Huang J, Li Y, Cheng J, Lin W, Cheng J, Chen W, Zhu Y, Jiang S, Hu X, Guo J, Wang H. Does intraoperative cyst rupture of malignant cystic renal masses really have no negative impact on oncologic outcomes? World J Surg Oncol. 2022 Nov 25;20(1):369. doi: 10.1186/s12957-022-02824-7.
PubMed 36434718Bertolo R, Campi R, Amparore D; European Association of Urology (EAU) Young Academic Urologists (YAU) Renal Cancer Working Group. YAU renal cancer SPOTLIGHT: the understated challenge of tumor rupture during robotic partial nephrectomy. Minerva Urol Nephrol. 2025 Jun;77(3):417-421. doi: 10.23736/S2724-6051.25.06509-7. No abstract available.
PubMed 40528779
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retro-Prospective Observational Study on Causes, Characteristics, Intraoperative Management and Impact on Prognosis
- ClinicalTrials.gov ID
- NCT07065825
- Acronym / sponsor ID
- RUPTURE / 674CET
- Conditions
- Kidney Cancer, Renal Neoplasms
- Keywords
- robotic, robotic surgery, partial nephrectomy, tumor rupture, tumour rupture, tumor resection, kidney cancer, small renal mass
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Collaborators
- Fundación Investigación Hospital IMED Valencia, Valencia, Spain, Hospital Clinic of Barcelona, The Cleveland Clinic, Fundacio Puigvert, San Raffaele University Hospital, Italy, Guy's and St Thomas' NHS Foundation Trust, University Hospital, Bordeaux, Fox Chase Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Azienda Ospedaliero-Universitaria Careggi, San Luigi Gonzaga Hospital, Changhai Hospital, St. George's Hospital, London, Frimley Health NHS Foundation Trust, Icahn School of Medicine at Mount Sinai, Rennes University Hospital, University of Illinois at Chicago, University of California, San Diego, Hospital da Luz Lisboa, Portugal, Swedish Medical Center, IRCCS Azienda Ospedaliero-Universitaria di Bologna, St. Antonius Hospital Gronau, Regina Elena Cancer Institute, Pitié-Salpêtrière Hospital, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Onze Lieve Vrouwziekenhuis Aalst, Hannover Medical School, Royal Free and University College Medical School, Università degli Studi del Piemonte Orientale Amedeo Avogadro, Memorial Sloan Kettering Cancer Center, The Netherlands Cancer Institute, A.O.U. Città della Salute e della Scienza - Molinette Hospital, University Medical Centre Ljubljana
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 15 Jul 2025 (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 RUPTURE Project is a multi-center observational study aiming to understand tumor rupture during robotic partial nephrectomy (RAPN), a minimally invasive surgery used to treat kidney tumors. Tumor rupture-an unintended break of the tumor capsule during surgery-occurs in about 10-15% of cases but is poorly studied. This event may increase the risk of cancer recurrence or spread, but its true impact is still unclear.
The study includes adult patients who experienced a tumor rupture during RAPN. Researchers will collect data on patient and tumor characteristics, surgical techniques, how the rupture occurred and was managed, and long-term outcomes. Follow-up visits will monitor for recurrence, metastases, and survival for up to five years. No experimental treatments or extra procedures are involved; only standard care is followed.
By analyzing at least 100 cases from various hospitals, the study hopes to clarify whether tumor rupture affects prognosis and to identify risk factors and best practices for managing it. This could help improve patient safety, surgical strategies, and future clinical guidelines. All data are handled confidentially, and participation is voluntary.
Detailed description
Background Robotic-assisted partial nephrectomy (RAPN) is a common, minimally invasive surgery used to remove kidney tumors while preserving healthy kidney tissue. While generally safe and effective, a complication called tumor rupture may occasionally occur. This means the tumor capsule (its outer layer) breaks during surgery, sometimes causing cancer cells to spill into the body. Although reported in up to 15% of surgeries, tumor rupture is not well understood, and its impact on long-term cancer outcomes remains unclear.
Purpose of the Study
This study, called the RUPTURE Project, aims to better understand tumor rupture during RAPN by answering key questions:
Does tumor rupture affect cancer recurrence or survival?
What causes it?
How can it be effectively managed during surgery?
How the Study Works This is a retro-prospective observational study, meaning it collects and analyzes both past and future cases of tumor rupture during RAPN. It involves multiple hospitals and surgical centers.
Who Can Participate? The study includes adult patients (18-80 years) who experienced a tumor rupture during RAPN and agree to participate. It excludes patients who had a radical nephrectomy (complete kidney removal), underwent open or laparoscopic surgery instead of robotic surgery, or had other complex medical conditions affecting the kidneys.
What Data Is Collected?
No additional procedures are required beyond standard clinical care. The study gathers information about:
Patient characteristics (age, health status, kidney function)
Tumor characteristics (size, location, type)
Surgical details (how the rupture occurred, surgical tools used, and how the situation was managed)
Pathological analysis (tumor grade, stage, margins)
Follow-up outcomes, including:
Local recurrence of the tumor
Spread (metastasis) to other parts of the body
Cancer-related and all-cause survival over a 5-year period
Why This Study Matters
Currently, there are no standardized guidelines for managing tumor rupture during kidney surgery. The RUPTURE Project will provide essential information to help:
Predict when and why ruptures occur
Guide surgeons on best practices during rupture events
Understand the long-term impact on patient health
Impact on Patients and Health Providers
The results of this study could lead to:
Safer surgeries with fewer complications
Improved guidelines for managing tumor rupture
Better information for patients facing kidney surgery
Potential changes in how surgeons plan and respond to complications
Study Duration The study will collect data over 2 years and follow up with patients for at least 5 years. A total of 100 or more cases of tumor rupture are expected to be analyzed across multiple centers.
Ethical and Privacy Considerations Participation is voluntary, and all patient data is handled confidentially, in compliance with European and Italian privacy laws (GDPR and national regulations). No experimental treatments or changes to care are made-this is strictly an observational study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who experienced tumor rupture during robotic partial nephrectomy | – | Procedure: robot-assisted partial nephrectomyPatients who experienced tumor rupture during RAPN (referred to an unintended breach of the tumor capsule with or without spillage of malignant tissue during tumor resection) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of interest comprises all patients undergoing RAPN for renal mass.
Key inclusion criteria (3 listed)
- Patients who experienced tumor rupture during RAPN (referred to an unintended breach of the tumor capsule with or without spillage of malignant tissue during tumor resection)
- Patients who provide informed consent to participate
- Patients from 18 to 80 years of age.
Key exclusion criteria (5 listed)
- Patients undergoing radical nephrectomy or other nephron-sparing procedures.
- Patients undergoing partial nephrectomy with other approaches (open, pure laparoscopic)
- Patients with multiple ipsilateral tumors
- Patients diagnosed with genetic abnormalities that increase the likelihood of developing renal cell carcinoma.
- Patients who deny consent.
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 |
|---|---|---|
| robot-assisted partial nephrectomyAlso: robotic partial nephrectomy, RAPN, RPNRobotic-Assisted Partial Nephrectomy (RAPN) is a minimally invasive surgical procedure performed with the help of a robotic system to remove a kidney tumor while preserving as much healthy kidney tissue as possible. It is commonly used to treat small to medium-sized kidney tumors. Thanks to the precision of robotic technology, RAPN offers faster recovery, less postoperative pain, and fewer complications compared to traditional open surgery. | Procedure or surgery | Patients who experienced tumor rupture during robotic partial nephrectomy |
Primary outcome
cumulative incidence of recurrences
Time frame: From date of enrolment until the date of first documented event, assessed up to 60 months
cumulative incidence of tumor local recurrences (at surgery site)
Cumulative incidence of Metastases
Time frame: From date of enrolment until the date of first documented event, assessed up to 60 months
cumulative incidence of tumor distant metastases
Cumulative incidence of Cancer-related Deaths
Time frame: From date of enrolment until the date of first documented event, assessed up to 60 months
Cumulative incidence of cancer-related deaths (deaths due to the disease). This will be evaluated through cancer-specific survival (CSS)
Cumulative incidence of All-cause Deaths
Time frame: From date of enrolment until the date of first documented event, assessed up to 60 months
Cumulative incidence of non-cancer-related deaths (deaths due to other cause) disease). This will be evaluated through overall survival (OS)
4 secondary outcomes
Timing of tumor rupture
Time frame: During surgery
type of tumor rupture
Time frame: During surgery
Cause of rupture
Time frame: During surgery
Surgical instrument causing the rupture
Time frame: During surgery
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 15 Jul 2025.
- Background: PubMed 36434718Xu P, Zhang S, Cao B, Huang J, Li Y, Cheng J, Lin W, Cheng J, Chen W, Zhu Y, Jiang S, Hu X, Guo J, Wang H. Does intraoperative cyst rupture of malignant cystic renal masses really have no negative impact on oncologic outcomes? World J Surg Oncol. 2022 Nov 25;20(1):369. doi: 10.1186/s12957-022-02824-7.
- Background: PubMed 40528779Bertolo R, Campi R, Amparore D; European Association of Urology (EAU) Young Academic Urologists (YAU) Renal Cancer Working Group. YAU renal cancer SPOTLIGHT: the understated challenge of tumor rupture during robotic partial nephrectomy. Minerva Urol Nephrol. 2025 Jun;77(3):417-421. doi: 10.23736/S2724-6051.25.06509-7. No abstract available.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Cancer and Renal Neoplasms, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
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 5 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: opening soon, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative incidence of recurrences (time frame: From date of enrolment until the date of first documented event, assessed up to 60 months). The study lists 4 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 NCT07065825, which also lists 2 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 15 Jul 2025.