Identification and Description of Patients With High-risk Non Metastatic RCC
HIROES
1 other identifier
observational
6,109
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 17, 2026
CompletedFirst Submitted
Initial submission to the registry
July 20, 2026
CompletedFirst Posted
Study publicly available on registry
August 7, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 17, 2028
August 7, 2026
May 1, 2026
2 years
July 20, 2026
August 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
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.
From 2014/01/01 to 2023/12/31
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).
From 2014/01/01 to 2023/12/31
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.
From 2014/01/01 to 2023/12/31
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.
From 2014/01/01 to 2023/12/31
Description the natural post-operative course of localised and locally advanced RCC according to the UroPredict 2 classification in the total, ncRCC and ccRCC populations, according to fulfillment of the KEYNOTE-564 eligibility criteria (2).
Disease Free Survival (DFS) is defined as the time from surgery until the first documented disease recurrence or death from any cause, whichever occurs first. Patients will be classified as 'Very low risk', 'Low risk', 'Medium risk' and 'High risk' according to UroPredict 2.
From 2014/01/01 to 2023/12/31
Description the natural post-operative course of localised and locally advanced RCC according to the UroPredict 2 classification in the total, ncRCC and ccRCC populations, according to fulfillment of the KEYNOTE-564 eligibility criteria. (3)
Local recurrence-free survival (LRFS) is defined as the time from surgery until the first documented local recurrence of the disease or death from any cause, whichever occurs first. Patients will be classified as 'Very low risk', 'Low risk', 'Medium risk' and 'High risk' according to UroPredict 2.
From 2014/01/01 to 2023/12/31
Description the natural post-operative course of localised and locally advanced RCC according to the UroPredict 2 classification in the total, ncRCC and ccRCC populations, according to fulfillment of the KEYNOTE-564 eligibility criteria.(4)
Progression-free survival (PFS) is defined as the time from surgery until the first documented disease progression, recurrence, or death from any cause, whichever occurs first. Patients will be classified as 'Very low risk', 'Low risk', 'Medium risk' and 'High risk' according to UroPredict 2.
From 2014/01/01 to 2023/12/31
Identification of the predictors of favorable response to immunotherapy among high-risk patients with ccRCC meeting the KEYNOTE-564 eligibility criteria who subsequently developed metachronous metastatic recurrence and were treated with immunotherapy.
Clinical, biological, anatomopathological and molecular factors associated with response to immunotherapy, defined by tumour response status (RC or RP vs SD or PD) in high-risk ccRCC patients according to Keynote 564 who have developed metachronous metastatic recurrence.
From 2014/01/01 to 2023/12/31
Analyse of the care pathways for patients with non-metastatic RCC (total population, the ncRCC population and the ccRCC population)..
Hospital admissions related to RCC; Surgical procedures, radiotherapy and systemic treatments (including bisphosphonates and denosumab); Diagnostic and follow-up investigations: imaging, laboratory tests, consultations (oncology, urology and others).
From 2014/01/01 to 2023/12/31
Assesment of healthcare resource utilization and associated costs before and after disease recurrence.
Total reimbursed healthcare costs associated with the management of patients with RCC, before and after disease recurrence.
From 2014/01/01 to 2023/12/31
Estimation of the cost of adjuvant treatment in the high-risk RCC population (taking into account the results of the Keynote 564 trial and the cost of treatment).
Total cost of adjuvant immunotherapy (pembrolizumab or nivolumab/ipilimumab) in the high-risk RCC population, expressed on a per-patient basis and extrapolated to the target population, incorporating efficacy data from the KEYNOTE-564 trial.
From 2014/01/01 to 2023/12/31
Assesment of the correlation between DFS and OS within the high-risk RCC population.
Comparison between DFS and OS in the high-risk RCC population.
From 2014/01/01 to 2023/12/31
Assement of the the impact of long-term post-operative use of aspirin on the incidence of disease recurrence (total population, the ncRCC population and the ccRCC population). (1)
Overall Survival (OS) according to the use of long-term post-operative aspirin.
From 2014/01/01 to 2023/12/31
Assement of the the impact of long-term post-operative use of aspirin on the incidence of disease recurrence (total population, the ncRCC population and the ccRCC population). (2)
Disease Free Survival (DFS) according to the use of long-term post-operative aspirin.
From 2014/01/01 to 2023/12/31
Assement of the impact of the time to recurrence, as well as associated factors (site of recurrence, number of lesions), on OS.
OS according to the time to recurrence (early, intermediate or late) and associated factors (site of recurrence, number of lesions).
From 2014/01/01 to 2023/12/31
Study Arms (3)
Overall RCC population
Patients diagnosed with local RCC or high-risk locally advanced RCC.
Non clear RCC population
Non clear RCC population
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
Interventions
Clear RCC population stratified by eligibility based on the Keynote-564 study criteria
Eligibility Criteria
see Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients not linked between UroCCR and SNDS datasources,
- Patients with hereditary RCC.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Bordeaux
Bordeaux, 33000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Christophe BERNHARD, Pr
University Hospital, Bordeaux
Central Study Contacts
Gaelle MARGUE, Dr
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2026
First Posted
August 7, 2026
Study Start
April 17, 2026
Primary Completion (Estimated)
April 17, 2028
Study Completion (Estimated)
April 17, 2028
Last Updated
August 7, 2026
Record last verified: 2026-05