Clear Cell Renal Cell CarcinomaPEP-CNCT04053855
Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma
An observational study of Clear Cell Renal Cell Carcinoma, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Clear cell renal cell carcinoma is diagnosed by imaging, sometimes associated with biopsy. This diagnosis is expensive, invasive and sometimes late. The development of a simple biological test for diagnosis is essential. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma
- What is being tested?
- Urinary sample
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jan 2020to 1 Aug 2026
- 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: 60 patients and 40 control will be included.
Who may be able to join
- Patients:
- All patients with renal mass requiring surgery (partial or total nephrectomy)
- Social security affiliation
- Signed informed consent
- Control :
- Unscheduled nephrectomy
- Social security affiliation
- Signed informed consent
Who cannot join
- Insufficient volume of urine sample (< 100 ml)
- Patients with a urinary catheter
- Patients under court-ordered guardianship or curators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Saint-Etienne
Saint-Etienne
Nicolas MOTTET, MD PhD
Hocine HABCHI, MD
About this study
Clear cell renal cell carcinoma is diagnosed by imaging, sometimes associated with biopsy. This diagnosis is expensive, invasive and sometimes late. The development of a simple biological test for diagnosis is essential. Exosomes are 30 to 150 nm membrane vesicles secreted into the extracellular space by various living cells. These exosomes can be isolated from biological fluids, including urine. The recent study of urinary exosomes is a promising topic for analyzing tumor markers in urine. The investigator's goal is to develop a reliable technique for detecting tumor exosomes in urine in patients with clear cell renal cell carcinoma. The analysis of urinary exosomes could provide a new liquid biopsy tool for the early diagnosis of clear cell renal cell carcinoma.
Read the detailed description
The primary objective is to detect urinary exosomes, by electron microscopy technique, from clear cell renal cell carcinoma due to exosome markers (CD9) and clear cell kidney cancer (CA9).
- Conditions
- Clear Cell Renal Cell Carcinoma
- Being tested
- Urinary sample
- Keywords
- Clear cell renal cell carcinoma, Urinary exosomes, Detection, Electron microscopy technique, Flow cytometry, RT-qPCR
- 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.
Urinary sampleBiological
Urinary sample (100 ml) will be collected in the urology department to analysis urinary exosomes.
| Study group | Role | What they receive |
|---|---|---|
| Renal mass patients | Patients with renal mass requiring surgery (partial or total nephrectomy) will be included.
They will have an urinary sample. Receives: Biological: Urinary sample | |
| Control patients | Control patients (without renal mass) will be included. They will have an urinary sample. Receives: Biological: Urinary sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients (with clear cell kidney cancer) with CD9+ and CA9+ exosomes by electron microscopy technique
Measured by analysis in electron microscopy technique of urinary sample.
Measured: At inclusion
Secondary outcomes (18)
Percentage of CD9+ /CA9+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer
Measured by analysis in electron microscopy technique of urinary sample.
Measured: At inclusion
Percentage of CD9+ /CA9+ exosomes by electron microscopy technique (%) for control patients
Measured by analysis in electron microscopy technique of urinary sample.
Measured: At inclusion
Percentage of CD9+ /CA9+ exosomes by flow cytometry (%) for patients with clear cell kidney cancer
Measured by analysis in flow cytometry of urinary sample.
Measured: At inclusion
Percentage of CD9+ /CA9+ exosomes by flow cytometry (%) for control patients
Measured by analysis in flow cytometry of urinary sample.
Measured: At inclusion
Percentage of CD9+ /CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for control patients
Measured by analysis in Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) of urinary sample.
Measured: At inclusion
Percentage of CD9+ /CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for patients with clear cell kidney cancer
Measured by analysis in Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) of urinary sample.
Measured: At inclusion
Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer
Measured by analysis in electron microscopy technique of urinary sample.
Measured: At inclusion
Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by electron microscopy technique (%) for control patients
Measured by analysis in electron microscopy technique of urinary sample.
Measured: At inclusion
Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by flow cytometry (%) for patients with clear cell kidney cancer
Measured by analysis in flow cytometry of urinary sample.
Measured: At inclusion
Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by flow cytometry (%) for control patients
Measured by analysis in flow cytometry of urinary sample.
Measured: At inclusion
Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for patients with clear cell kidney cancer
Measured by analysis in Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) of urinary sample.
Measured: Years: 2
Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for control patients
Measured by analysis in Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) of urinary sample.
Measured: Years: 2
Percentage of CD9+/VGEFR2+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer
Measured by analysis in electron microscopy technique of urinary sample.
Measured: At inclusion
Percentage of CD9+/VGEFR2+ exosomes by electron microscopy technique (%) for control patients
Measured by analysis in electron microscopy technique of urinary sample.
Measured: At inclusion
Percentage of CD9+/VGEFR2+ exosomes by flow cytometry (%) for patients with clear cell kidney cancer
Measured by analysis in flow cytometry of urinary sample.
Measured: At inclusion
Percentage of CD9+/VGEFR2+ exosomes by flow cytometry (%) for control patients
Measured by analysis in flow cytometry of urinary sample.
Measured: At inclusion
Percentage of CD9+/VGEFR2+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for patients with clear cell kidney cancer
Measured by analysis in Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) of urinary sample.
Measured: At inclusion
Percentage of CD9+/VGEFR2+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for control patients
Measured by analysis in Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) of urinary sample.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start29 Jan 2020
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas MOTTET, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint EtienneNora MALLOUK, PhD, Study chair, UNIVERSITY SAINT-ETIENNEGuorong LI, PhD, Study chair, CHU DE SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053855
- Sponsor's protocol ID
- 19CH048
- Other IDs
- 2019-A01408-49
- Acronym
- PEP-C
- Status last verified
- May 2026
- First submitted
- 9 Aug 2019
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li G, Mallouk N, Flandrin P, Garcin A, Lambert C, Berremila SA, Habchi H, Mottet N. Presence of Urinary Exosomes for Liquid Biopsy of Clear Cell Renal Cell Carcinoma: Protocol for a Pilot Feasibility Study. JMIR Res Protoc. 2021 Jul 20;10(7):e24423. doi: 10.2196/24423.
PubMed 34283029
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04053855
- Acronym / sponsor ID
- PEP-C / 19CH048
- Conditions
- Clear Cell Renal Cell Carcinoma
- Keywords
- Clear cell renal cell carcinoma, Urinary exosomes, Detection, Electron microscopy technique, Flow cytometry, RT-qPCR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 13 Aug 2019 (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.
Clear cell renal cell carcinoma is diagnosed by imaging, sometimes associated with biopsy. This diagnosis is expensive, invasive and sometimes late. The development of a simple biological test for diagnosis is essential. Exosomes are 30 to 150 nm membrane vesicles secreted into the extracellular space by various living cells. These exosomes can be isolated from biological fluids, including urine. The recent study of urinary exosomes is a promising topic for analyzing tumor markers in urine. The investigator's goal is to develop a reliable technique for detecting tumor exosomes in urine in patients with clear cell renal cell carcinoma. The analysis of urinary exosomes could provide a new liquid biopsy tool for the early diagnosis of clear cell renal cell carcinoma.
Detailed description
The primary objective is to detect urinary exosomes, by electron microscopy technique, from clear cell renal cell carcinoma due to exosome markers (CD9) and clear cell kidney cancer (CA9).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal mass patients | – | Biological: Urinary samplePatients with renal mass requiring surgery (partial or total nephrectomy) will be included. They will have an urinary sample. |
| Control patients | – | Biological: Urinary sampleControl patients (without renal mass) will be included. They will have an urinary sample. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 patients and 40 control will be included.
Key inclusion criteria (8 listed)
- All patients with renal mass requiring surgery (partial or total nephrectomy)
- Social security affiliation
- Signed informed consent
- Unscheduled nephrectomy
- Social security affiliation
Key exclusion criteria (3 listed)
- Insufficient volume of urine sample (< 100 ml)
- Patients with a urinary catheter
- Patients under court-ordered guardianship or curators
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 |
|---|---|---|
| Urinary sampleUrinary sample (100 ml) will be collected in the urology department to analysis urinary exosomes. | Biological | Control patients, Renal mass patients |
Primary outcome
Number of patients (with clear cell kidney cancer) with CD9+ and CA9+ exosomes by electron microscopy technique
Time frame: At inclusion
Measured by analysis in electron microscopy technique of urinary sample.
18 secondary outcomes
Percentage of CD9+ /CA9+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer
Time frame: At inclusion
Percentage of CD9+ /CA9+ exosomes by electron microscopy technique (%) for control patients
Time frame: At inclusion
Percentage of CD9+ /CA9+ exosomes by flow cytometry (%) for patients with clear cell kidney cancer
Time frame: At inclusion
Percentage of CD9+ /CA9+ exosomes by flow cytometry (%) for control patients
Time frame: At inclusion
Percentage of CD9+ /CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for control patients
Time frame: At inclusion
Percentage of CD9+ /CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for patients with clear cell kidney cancer
Time frame: At inclusion
Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer
Time frame: At inclusion
Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by electron microscopy technique (%) for control patients
Time frame: At inclusion
Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by flow cytometry (%) for patients with clear cell kidney cancer
Time frame: At inclusion
Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by flow cytometry (%) for control patients
Time frame: At inclusion
Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for patients with clear cell kidney cancer
Time frame: Years: 2
Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for control patients
Time frame: Years: 2
Percentage of CD9+/VGEFR2+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer
Time frame: At inclusion
Percentage of CD9+/VGEFR2+ exosomes by electron microscopy technique (%) for control patients
Time frame: At inclusion
Percentage of CD9+/VGEFR2+ exosomes by flow cytometry (%) for patients with clear cell kidney cancer
Time frame: At inclusion
Percentage of CD9+/VGEFR2+ exosomes by flow cytometry (%) for control patients
Time frame: At inclusion
Percentage of CD9+/VGEFR2+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for patients with clear cell kidney cancer
Time frame: At inclusion
Percentage of CD9+/VGEFR2+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for control patients
Time frame: At inclusion
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 6 May 2026.
- Derived from this study: PubMed 34283029Li G, Mallouk N, Flandrin P, Garcin A, Lambert C, Berremila SA, Habchi H, Mottet N. Presence of Urinary Exosomes for Liquid Biopsy of Clear Cell Renal Cell Carcinoma: Protocol for a Pilot Feasibility Study. JMIR Res Protoc. 2021 Jul 20;10(7):e24423. doi: 10.2196/24423.
- Individual participant dataSharing planned: No
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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.
Nicolas MOTTET, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
Nora MALLOUK, PhD study chair
UNIVERSITY SAINT-ETIENNE
Guorong LI, PhD study chair
CHU DE SAINT-ETIENNE
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 Clear Cell Renal Cell Carcinoma, run by Centre Hospitalier Universitaire de Saint Etienne 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 8 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 6 May 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 Nicolas MOTTET, MD PhD ((0)477828331 ext. +33, nicolas.mottet@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients (with clear cell kidney cancer) with CD9+ and CA9+ exosomes by electron microscopy technique (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04053855, which also lists 1 linked publication.
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 6 May 2026.