Renal Cell CarcinomaNCT07243067
Tumor-Derived Extracellular Vesicles for Noninvasive Molecular Classification of Kidney Cancer
An observational study of Renal Cell Carcinoma and Clear-cell Renal Cell Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This is a correlative (lab-based) study aiming to identify protein markers in urine extracellular vesicles (EVs) that can be used to develop non-invasive molecular tests for patients with renal cell carcinoma (RCC). Aim 1 will use urine collected previously in biorepository. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Cell Carcinoma, Clear-cell Renal Cell Carcinoma, Papillary Renal Cell Carcinoma
- What is being tested?
- Proteomic profiling of urinary EVs and Blood sample collection
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2026to 30 Apr 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Mayo Clinic patients scheduled to undergo nephrectomy for treatment of RCC.
Who may be able to join
- Urine sample in existing biorepository
- High-risk renal cell carcinoma (RCC) per American Urological Association (AUA) guidelines
- Scheduled to undergo nephrectomy
Who cannot join
- Does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Fabrice Lucien-Matteoni, MD
About this study
This is a correlative (lab-based) study aiming to identify protein markers in urine extracellular vesicles (EVs) that can be used to develop non-invasive molecular tests for patients with renal cell carcinoma (RCC). Aim 1 will use urine collected previously in biorepository. Aim 2 will prospectively collect blood specimens pre and post nephrectomy.
- Conditions
- Renal Cell Carcinoma, Clear-cell Renal Cell Carcinoma, Papillary Renal Cell Carcinoma, Chromophobe Renal Cell Carcinoma, Kidney Cancer
- Being tested
- Proteomic profiling of urinary EVs, Blood sample collection
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proteomic profiling of urinary EVsOther
EV isolation and mass spectrometry.
Blood sample collectionProcedure or surgery
Blood samples collected pre- and post-nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| Clear-cell RCC | Participants with clear-cell RCC Receives: Other: Proteomic profiling of urinary EVs; Procedure: Blood sample collection | |
| Papillary RCC | Participants with papillary RCC Receives: Other: Proteomic profiling of urinary EVs; Procedure: Blood sample collection | |
| Chromophobe RCC | Participants with chromophobe RCC Receives: Other: Proteomic profiling of urinary EVs; Procedure: Blood sample collection | |
| Benign Renal Tumor | Participants with benign renal tumors Receives: Other: Proteomic profiling of urinary EVs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differentiate tumor-derived extracellular vesicle (tdEV) surface proteins expressed in benign vs malignant renal tumors
Differential protein expression analysis will be performed on stored urine samples from a biorepository to identify tdEV proteins in each renal cell carcinoma (RCC) subtype (clear-cell, papillary, and chromophobe) versus benign.
Measured: Baseline
Prediction of metastasis after surgery
Blood samples will be collected pre-and post-nephrectomy to asses for tdEV levels which will be correlated with clinicopathological features to test whether tdEV levels can be used to better predict likelihood of metastasis in patients undergoing curative-intent radical nephrectomy.
Measured: Perioperative (pre- and post-nephrectomy),
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start15 Jul 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (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 Mayo ClinicThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice Lucien-Matteoni, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243067
- Sponsor's protocol ID
- 25-003121
- Other IDs
- HT9425-25-1-0607
- Status last verified
- Feb 2026
- First submitted
- 14 Nov 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor-Derived Extracellular Vesicles for Noninvasive Molecular Classification of Kidney Cancer
- ClinicalTrials.gov ID
- NCT07243067
- Acronym / sponsor ID
- 25-003121
- Conditions
- Renal Cell Carcinoma, Clear-cell Renal Cell Carcinoma, Papillary Renal Cell Carcinoma, Chromophobe Renal Cell Carcinoma, Kidney Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 21 Nov 2025 (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.
This is a correlative (lab-based) study aiming to identify protein markers in urine extracellular vesicles (EVs) that can be used to develop non-invasive molecular tests for patients with renal cell carcinoma (RCC). Aim 1 will use urine collected previously in biorepository. Aim 2 will prospectively collect blood specimens pre and post nephrectomy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Clear-cell RCC | – | Other: Proteomic profiling of urinary EVs, Procedure: Blood sample collectionParticipants with clear-cell RCC |
| Papillary RCC | – | Other: Proteomic profiling of urinary EVs, Procedure: Blood sample collectionParticipants with papillary RCC |
| Chromophobe RCC | – | Other: Proteomic profiling of urinary EVs, Procedure: Blood sample collectionParticipants with chromophobe RCC |
| Benign Renal Tumor | – | Other: Proteomic profiling of urinary EVsParticipants with benign renal tumors |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mayo Clinic patients scheduled to undergo nephrectomy for treatment of RCC.
Key inclusion criteria (3 listed)
- Urine sample in existing biorepository
- High-risk renal cell carcinoma (RCC) per American Urological Association (AUA) guidelines
- Scheduled to undergo nephrectomy
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria
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 |
|---|---|---|
| Proteomic profiling of urinary EVsEV isolation and mass spectrometry. | Other | Benign Renal Tumor, Chromophobe RCC, Clear-cell RCC, Papillary RCC |
| Blood sample collectionBlood samples collected pre- and post-nephrectomy | Procedure or surgery | Chromophobe RCC, Clear-cell RCC, Papillary RCC |
Primary outcome
Differentiate tumor-derived extracellular vesicle (tdEV) surface proteins expressed in benign vs malignant renal tumors
Time frame: Baseline
Differential protein expression analysis will be performed on stored urine samples from a biorepository to identify tdEV proteins in each renal cell carcinoma (RCC) subtype (clear-cell, papillary, and chromophobe) versus benign.
Prediction of metastasis after surgery
Time frame: Perioperative (pre- and post-nephrectomy),
Blood samples will be collected pre-and post-nephrectomy to asses for tdEV levels which will be correlated with clinicopathological features to test whether tdEV levels can be used to better predict likelihood of metastasis in patients undergoing curative-intent radical nephrectomy.
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 27 Feb 2026.
- Individual participant dataSharing planned: No
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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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
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Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
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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.
Fabrice Lucien-Matteoni, MD principal investigator
Mayo Clinic
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 and Clear-cell Renal Cell Carcinoma, run by Mayo Clinic at 1 site in United States.
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 1 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: opening soon, as of the sponsor's last update on 27 Feb 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 United States. 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 Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differentiate tumor-derived extracellular vesicle (tdEV) surface proteins expressed in benign vs malignant renal tumors (time frame: Baseline). The study lists 2 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 27 Feb 2026.