International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors (NCT05363657)
International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors (i-RECORd)
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (3 items).
Location: Institute of Urology, University of Southern California. — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
- Partial Nephrectomy (PN) (PROCEDURE)
- Radical Nephrectomy (RN) (PROCEDURE)
- Ablation therapy (AT) (PROCEDURE)
- Active Surveillance (AS) (DIAGNOSTIC_TEST)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patient refuse to participate in clinical research.
- Urothelial renal carcinoma.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (37 Sites)
Showing the first 25 of 37 sites.
- Institute of Urology, University of Southern California. — Los Angeles, California
- University of California San Diego, Moores Cancer Center — San Diego, California
- Stanford University — Stanford, California
- Loyola University Medical Center, Edward Hines VA Hospital — Chicago, Illinois
- University of Pennsylvania — Philadelphia, Pennsylvania
- VCU Health System — Richmond, Virginia
- Swedish Hospital — Seattle, Washington
- Medical University of Vienna, Vienna General Hospital — Vienna,
- University of Bruxelles — Brussels,
- University Hospitals Leuven — Leuven,
- Onze Lieve Vrouw Hospital — Leuven,
- Santa Casa da Misericórdia de Fortaleza — Fortaleza,
- University of Patras — Pátrai,
- Urology, Andrology & Kidney Transplantation Unit, University of Bari — Bari,
- Policlinico S. Orsola Malpighi — Bologna,
- Department of Urology, University of Florence, Unit of Oncologic Minimally-Invasive Urology and Andrology, Careggi Hospital — Florence,
- Policlinico Riuniti, Università di Foggia. — Foggia,
- Division of Urology, University of Genoa,Policlinico San Martino Hospital — Genova,
- Azienda Ospedaliera Policlinico "G. Martino", Università di Messina. — Messina,
- San Raffaele Scientific Institute, Milan, Italy; Division of Experimental Oncology/Unit of Urology, URI, IRCCS San Raffaele Hospital — Milan,
- Policlinico Istituto Europeo di Oncologia (IEO) — Milan,
- Istituto Nazionale dei Tumori Fondazione Senatore "G. Pascale" — Naples,
- Institute Oncology Veneto (IOV) — Padova,
- Humanitas Hospital — Rozzano,
- Università degli Studi di Torino, Ospedale S. Luigi Gonzaga. — Torino,
📞 Contact the Study Coordinator
Phone: (055) 794-6351
Email: carini@unifi.it
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.