NCT07065825Not yet recruiting
Tumor Rupture During Robotic Partial Nephrectomy
A Retro-Prospective Observational Study on Causes, Characteristics, Intraoperative Management and Impact on Prognosis
Source: ClinicalTrials.gov · Last updated 15 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 2 Jul 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Diseases
- Kidney cancer
- NCT number
- NCT07065825
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Sept 2025 to the primary completion date, 31 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AOUI Verona Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.