Tumor Rupture During Robotic Partial Nephrectomy

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.

NCT Number	NCT07065825
Lead Sponsor	Azienda Ospedaliera Universitaria Integrata Verona 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, Ospedale San Luigi Gonzaga, Orbassano, 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
Conditions	Kidney Cancer, Renal Neoplasms
Enrollment	100 participants
Start Date	2025-09
Primary Completion	2030-12 (estimated)
Study Completion	2030-12 (estimated)
Updated on ClinicalTrials.gov	2025-07-15