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NCT Number: NCT07753343

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

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

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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

    Time frame: From 2014/01/01 to 2023/12/31

    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.

  2. 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

    • 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).
    • Proportion of high-risk patients relative to the annual incidence of surgically treated renal cell carcinoma.
    • Estimated size of the eligible population extrapolated to the national level (France).

  3. 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

    Number and percentage (%) of patients classified as 'Very low risk', 'Low risk', 'Medium risk' and 'High risk' according to UroPredict 2.

  4. 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

    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.

  5. 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

    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.

  6. 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

    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.

  7. 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

    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.

  8. 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

    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.

  9. 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

    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).

  10. Assesment of healthcare resource utilization and associated costs before and after disease recurrence.

    Time frame: From 2014/01/01 to 2023/12/31

    Total reimbursed healthcare costs associated with the management of patients with RCC, before and after disease recurrence.

  11. 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).

    Time frame: From 2014/01/01 to 2023/12/31

    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.

  12. Assesment of the correlation between DFS and OS within the high-risk RCC population.

    Time frame: From 2014/01/01 to 2023/12/31

    Comparison between DFS and OS in the high-risk RCC population.

  13. 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)

    Time frame: From 2014/01/01 to 2023/12/31

    Overall Survival (OS) according to the use of long-term post-operative aspirin.

  14. 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)

    Time frame: From 2014/01/01 to 2023/12/31

    Disease Free Survival (DFS) according to the use of long-term post-operative aspirin.

  15. Assement of the impact of the time to recurrence, as well as associated factors (site of recurrence, number of lesions), on OS.

    Time frame: From 2014/01/01 to 2023/12/31

    OS according to the time to recurrence (early, intermediate or late) and associated factors (site of recurrence, number of lesions).

Study contacts

Contact information is provided by the study sponsor or research team.

Gaelle MARGUE, Dr

CONTACT

Jean-Christophe BERNHARD, Pr

CONTACT

[email protected]

0033540451179

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: HIROES

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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