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International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors
NCT05363657 · View on ClinicalTrials.gov ↗
Study Summary
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
Conditions Studied
Interventions
- PROCEDURE Partial Nephrectomy (PN)
- PROCEDURE Radical Nephrectomy (RN)
- PROCEDURE Ablation therapy (AT)
- DIAGNOSTIC_TEST Active Surveillance (AS)
Study Locations (20)
Other
- 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
California
- Institute of Urology, University of Southern California. — Los Angeles
- University of California San Diego, Moores Cancer Center — San Diego
- Stanford University — Stanford
Illinois
- Loyola University Medical Center, Edward Hines VA Hospital — Chicago
Pennsylvania
- University of Pennsylvania — Philadelphia
Virginia
- VCU Health System — Richmond
Washington
- Swedish Hospital — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,000 participants |
| Start Date | 2022-01-10 |
| Est. Completion | 2028-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05363657
The ClinicalTrials.gov registry entry for NCT05363657 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 10,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Azienda Ospedaliero-Universitaria Careggi, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Kidney Cancer appearing as the primary indexed condition, and to 4 interventions — of which Partial Nephrectomy (PN) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05363657 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Other, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05363657 about?
NCT05363657 is a clinical study titled "International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors". 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 out...
What is the current status of trial NCT05363657?
This trial is currently recruiting. The enrollment target is 10,000 participants. The study started on 2022-01-10. Estimated completion is 2028-12-31.
What conditions does trial NCT05363657 study?
This clinical trial studies the following conditions: Kidney Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05363657?
The interventions under investigation include: Partial Nephrectomy (PN) (PROCEDURE), Radical Nephrectomy (RN) (PROCEDURE), Ablation therapy (AT) (PROCEDURE), Active Surveillance (AS) (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05363657?
This trial is sponsored by Azienda Ospedaliero-Universitaria Careggi, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05363657 being conducted?
This trial has 20 study locations across California, Illinois, Pennsylvania, Virginia, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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