Identification and Description of Patients With High-risk Non Metastatic RCC

Sponsor
University Hospital, Bordeaux
Study ID
NCT07753343
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cohort 1 — OTHER
    Overall RCC Population
  • Cohort 2 — OTHER
    Non clear RCC population
  • Cohort 3 — OTHER
    Clear RCC population stratified by eligibility based on the Keynote-564 study criteria

Study Details

Renal cell carcinoma (RCC) is the 14th most common cancer worldwide. Surgery is the standard of care for localized RCC, however, the risk of recurrence varies widely among patients. Adjuvant pembrolizumab has been shown to improve outcomes after nephrectomy but is associated with substantial toxicity and high costs. This study uses real-world data from the French UroCCR-Chain registry to characterize the natural history, management, and outcomes of non-metastatic RCC in France, with the aim of informing adjuvant treatment decisions

Key Dates

First listed
Aug 7, 2026
Start date
Apr 17, 2026
Status verified
May 2026
Primary completion
Apr 17, 2028
Completion
Apr 17, 2028

Study Design

Enrollment
6,109 participants (estimated)

Arms

  • Arm: Overall RCC population
    Patients diagnosed with local RCC or high-risk locally advanced RCC.
  • Arm: Non clear RCC population
    Non clear RCC population
  • Arm: Clear RCC population stratified by eligibility based on the Keynote-564 study criteria
    Keynote-564 study criteria: pT2 grade 4, pT3-T4 with any N and any grade, any T with N1, all M0

Primary Outcome Measure

Description of the natural evolution of the disease in the overall RCC population and in the ncRCC and cRCC subgroups according to the inclusion criteria of the KEYNOTE-564 study. [ Time Frame: From 2014/01/01 to 2023/12/31 ]

Central Contacts

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