Renal Cell CarcinomaHIROESNCT07753343
Identification and Description of Patients With High-risk Non Metastatic RCC
An observational study of Renal Cell Carcinoma, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Cohort 1, Cohort 2 and Cohort 3
- How many people
- 6,109 participants
- Where
- 1 siteFrance
- Study dates
- 17 Apr 2026to 17 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: see Eligibility Criteria
Who may be able to join
- 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.
Who cannot join
- Patients with metastatic disease at inclusion,
- Patients not linked between UroCCR and SNDS datasources,
- Patients with hereditary RCC.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gaelle MARGUE, Dr contact
France1 site, 1 recruiting
- Recruiting
CHU Bordeaux
Bordeaux, 33000
Jean-Christophe BERNHARD, Pr, 0033540451179, jean-christophe.bernhard@chu-bordeaux.fr
About this study
Official title: Identification and Description of Patients With High-risk Non Metastatic RCC (UroCCR 127)
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
Read the 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).
- Conditions
- Renal Cell Carcinoma
- Being tested
- Cohort 1, Cohort 2, Cohort 3
- Keywords
- renal cell carcinoma (RCC) high-risk RCC, real life, UroCCR, UroCCR-Chain
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort 1Other
Overall RCC Population
Cohort 2Other
Non clear RCC population
Cohort 3Other
Clear RCC population stratified by eligibility based on the Keynote-564 study criteria
| Study group | Role | What they receive |
|---|---|---|
| Overall RCC population | Patients diagnosed with local RCC or high-risk locally advanced RCC. Receives: Other: Cohort 1 | |
| Non clear RCC population | Non clear RCC population Receives: Other: Cohort 2 | |
| 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 Receives: Other: Cohort 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
- 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: From 2014/01/01 to 2023/12/31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start17 Apr 2026
- Primary completion17 Apr 2028 (estimated)
- Study completion17 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,109 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe BERNHARD, Pr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753343
- Sponsor's protocol ID
- CHUBX 2025/056
- Acronym
- HIROES
- Status last verified
- May 2026
- First submitted
- 20 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Description of Patients With High-risk Non Metastatic RCC (UroCCR 127)
- ClinicalTrials.gov ID
- NCT07753343
- Acronym / sponsor ID
- HIROES / CHUBX 2025/056
- Conditions
- Renal Cell Carcinoma
- Keywords
- renal cell carcinoma (RCC) high-risk RCC, real life, UroCCR, UroCCR-Chain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,109 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 17 Apr 2028 (estimated)
- Study completion
- 17 Apr 2028 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Overall RCC population | – | Other: Cohort 1Patients diagnosed with local RCC or high-risk locally advanced RCC. |
| Non clear RCC population | – | Other: Cohort 2Non clear RCC population |
| Clear RCC population stratified by eligibility based on the Keynote-564 study criteria | – | Other: Cohort 3Keynote-564 study criteria: pT2 grade 4, pT3-T4 with any N and any grade, any T with N1, all M0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- see Eligibility Criteria
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with metastatic disease at inclusion,
- Patients not linked between UroCCR and SNDS datasources,
- Patients with hereditary RCC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cohort 1Overall RCC Population | Other | Overall RCC population |
| Cohort 2Non clear RCC population | Other | Non clear RCC population |
| Cohort 3Clear RCC population stratified by eligibility based on the Keynote-564 study criteria | Other | Clear RCC population stratified by eligibility based on the Keynote-564 study criteria |
Primary outcome
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.
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
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).
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
Related trials for Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gaelle MARGUE, Dr contact
Jean-Christophe BERNHARD, Pr principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Christophe BERNHARD, Pr (0033540451179, jean-christophe.bernhard@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.