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

Official title

Identification and Description of Patients With High-risk Non Metastatic RCC (UroCCR 127)

Overview

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

Detailed description

Renal cell carcinoma (RCC) is the 14th most common malignant tumour worldwide, with 431,288 new cases reported in 2020. The standard treatment for localised and locally advanced renal tumours is partial or radical nephrectomy. However, 5-year postoperative recurrence-free survival rates vary widely, ranging from 10% to 95%. Currently, there is a lack of reliable, accurate, and up-to-date prognostic models to predict the risk of disease recurrence after surgery.

Recently, the phase 3 clinical trial Keynote 564 demonstrated that adjuvant pembrolizumab, administered for one year following surgery, significantly improves disease-free survival (DFS) and overall survival (OS). Nevertheless, many patients experienced adverse effects, and the high cost of treatment remains a major concern.

Therefore, precise postoperative risk assessment for progression in patients with localised or locally advanced RCC is essential. This enables clinicians to identify candidates most likely to benefit from adjuvant therapy, weigh the potential risks and benefits, and ensure cost-effective use of healthcare resources. In France, pembrolizumab has been available since December 2023-initially through early access programmes and subsequently via marketing authorisation-for patients identified as being at "high risk of recurrence."

However, contemporary real-world data from France remain scarce regarding the accurate characterisation of these high-risk patients and the medical and economic impact of introducing this adjuvant therapy.

The aim of this study is to expand current knowledge on the natural history, management, and clinical outcomes of non-metastatic RCC in France, particularly in the high-risk population, by leveraging data from UroCCR-Chain. This registry, derived from our kidney cancer-specific Health Data Warehouse (UroCCR), is referenced by both the French National Cancer Institute (INCa) and the French National Authority for Health (HAS), and is linked to the French National Health Data System (SNDS).

Interventions

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

Primary outcome measures

• 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]
• 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. [Time frame: 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. [Time frame: 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) [Time frame: 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). [Time frame: 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) [Time frame: 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) [Time frame: 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. [Time frame: 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).. [Time frame: From 2014/01/01 to 2023/12/31]
• Assesment of healthcare resource utilization and associated costs before and after disease recurrence. [Time frame: From 2014/01/01 to 2023/12/31]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• Patients with metastatic disease at inclusion,
• Patients not linked between UroCCR and SNDS datasources,
• Patients with hereditary RCC.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 1 center

• CHU Bordeaux — Bordeaux

Identifiers

NCT: NCT07753343 · CHUBX 2025/056

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗