Identification and Description of Patients With High-risk Non Metastatic RCC
ConditionRenal Cell Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients diagnosed with local RCC or high-risk locally advanced RCC,
Included in UroCCR register between 1st january 2014 and 31st december 2023,
Consenting to participate in UroCCR and UroCCR-Chain registers.
Disqualifiers
Patients with metastatic disease at inclusion,
Patients not linked between UroCCR and SNDS datasources,
Patients with hereditary RCC.
Trial population
see Eligibility Criteria
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Cohort 1
Other interventionOverall RCC Population
Cohort 2
Other interventionNon clear RCC population
Cohort 3
Other interventionClear RCC population stratified by eligibility based on the Keynote-564 study criteria
Treatment groups
6,109 Participants
are divided into 3 treatment groupsGroup A: Overall RCC population1 intervention
Group B: Non clear RCC population1 intervention
Group C: Clear RCC population stratified by eligibility based on the Keynote-564 study criteria1 intervention
Trial outcomes
Primary outcomes
1
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.
Assessment of time to first occurrence of the event of interest (disease-free survival, DFS, local recurrence-free survival, LRFS, or progression-free survival, PFS) or death from any cause (overall survival, OS), whichever occurs first.
Time frame
From 2014/01/01 to 2023/12/312
Description of the characteristics of the overall RCC population, the ncRCC and ccRCC subgroups, according to whether or not they met the Keynote-564 study eligibility criteria.
1. Number and proportion (%) of patients eligible for adjuvant therapy among those who underwent surgery for non-metastatic renal cell carcinoma, according to predefined eligibility criteria (ccRCC pT2 grade 4, pT3-T4 of any grade, pTany N1 of any grade, M0). 2. Proportion of high-risk patients relative to the annual incidence of surgically treated renal cell carcinoma. 3. Estimated size of the eligible population extrapolated to the national level (France).
Time frame
From 2014/01/01 to 2023/12/313
Description of the distribution of UroPredict 2 prognostic risk categories among patients with ccRCC, stratified according to fulfillment of the KEYNOTE-564 eligibility criteria.
Number and percentage (%) of patients classified as 'Very low risk', 'Low risk', 'Medium risk' and 'High risk' according to UroPredict 2.
Time frame
From 2014/01/01 to 2023/12/314
Description the natural post-operative course of localised and locally advanced RCC (1)according to the UroPredict 2 classification in the total, ncRCC and ccRCC populations, according to fulfillment of the KEYNOTE-564 eligibility criteria (1)
Overall Survival (OS) is defined as the time from surgery to death from any cause. Patients will be classified as 'Very low risk', 'Low risk', 'Medium risk' and 'High risk' according to UroPredict 2.
Time frame
From 2014/01/01 to 2023/12/31Sponsors and contacts
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Source ClinicalTrials.gov