Tumor-Derived Extracellular Vesicles for Noninvasive Molecular Classification of Kidney Cancer

NCT07243067 — Not yet recruiting, 300 participants, Mayo Clinic

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Registry	NCT07243067
Status	Not yet recruiting
Study type	Observational
Enrollment	300 (Estimated)
Sponsor	Mayo Clinic (Other)
Conditions	Renal Cell Carcinoma, Clear-cell Renal Cell Carcinoma, Papillary Renal Cell Carcinoma, Chromophobe Renal Cell Carcinoma, Kidney Cancer
Interventions	Proteomic profiling of urinary EVs, Blood sample collection (Other, procedure)
Dates	start 2026-07-15 (estimated), primary completion 2027-04-30 (estimated), completion 2027-04-30 (estimated), first posted 2025-11-21, last updated 2026-02-27
Locations	1 site in United States

-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. Aim 2 will prospectively collect blood specimens pre and post nephrectomy.

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+Arms and interventions

Arm	Interventions	Description
Clear-cell RCC	Other: Proteomic profiling of urinary EVs; Procedure: Blood sample collection	Participants with clear-cell RCC
Papillary RCC	Other: Proteomic profiling of urinary EVs; Procedure: Blood sample collection	Participants with papillary RCC
Chromophobe RCC	Other: Proteomic profiling of urinary EVs; Procedure: Blood sample collection	Participants with chromophobe RCC
Benign Renal Tumor	Other: Proteomic profiling of urinary EVs	Participants with benign renal tumors

Proteomic profiling of urinary EVs (Other): EV isolation and mass spectrometry.
Blood sample collection (Procedure): Blood samples collected pre- and post-nephrectomy

+Outcome measures

Primary outcomes

Differentiate tumor-derived extracellular vesicle (tdEV) surface proteins expressed in benign vs malignant renal tumors [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 [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.

+Eligibility

Sex: All

Inclusion Criteria:

* Urine sample in existing biorepository
* High-risk renal cell carcinoma (RCC) per American Urological Association (AUA) guidelines
* Scheduled to undergo nephrectomy

Exclusion Criteria:

* Does not meet inclusion criteria

+Locations (1)

Facility	City	Country	Status
Mayo Clinic in Rochester	Rochester, Minnesota	United States

+Investigators

Fabrice Lucien-Matteoni, MD, Principal investigator, Mayo Clinic