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NCT05363657 · ClinicalTrials.gov registry record
International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors
A clinical trial of Kidney Cancer, sponsored by Azienda Ospedaliero-Universitaria Careggi.
- Recruiting
- Registry status
- 10,000
- Enrollment target
- 20
- Study locations
NCT05363657: Recruiting study of Kidney Cancer, sponsored by Azienda Ospedaliero-Universitaria Careggi.
NCT05363657 is a study of Kidney Cancer that is actively recruiting participants, run by Azienda Ospedaliero-Universitaria Careggi. The registered enrollment target is 10,000 participants, above the 714-participant average among 60 other Kidney Cancer trials with a reported enrollment target (1301% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05363657, a study of Kidney Cancer, is actively recruiting participants, sponsored by Azienda Ospedaliero-Universitaria Careggi.
- RECRUITING
- Registry status
- 10,000 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
The preoperative characteristics of the patients will be specifically evaluated to calculate any heterogeneity between the two groups. In detail, anthropometric and comorbidity features, previous abdominal surgery, blood chemistry values, blood pressure, smoking habit, preoperative life expectancy, and frailty grade will be assessed. Imaging features of the tumor will be considered, including the characteristics necessary for the calculation of the PADUA, R.E.N.A.L., and Contact-Surface-Area sco
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 |
What NCT05363657 shows while recruiting
NCT05363657 is an observational study that tracks outcomes without assigning an intervention. Its 10,000 participants enrollment target places it among the larger protocols in the corpus, above the 714-participant average among 60 other Kidney Cancer trials with a reported enrollment target (1301% higher).
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.
NCT05363657 names 20 study sites across 6 states, led by Other, California, Illinois.
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.
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).
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.
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.
Learn More About Clinical Trials
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Where NCT05363657's enrollment target sits among peer trials
10,000 2nd of 60 the highest of 60 other Kidney Cancer trials
participants (enrollment target), bucketed by value
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