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

NCT07243067 | Not Yet Recruiting

• 2 other identifiers: 25-003121HT9425-25-1-0607
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Cell Carcinoma; Clear-cell Renal Cell Carcinoma; Papillary Renal Cell Carcinoma; Chromophobe Renal Cell Carcinoma; Kidney Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Perioperative (pre- and post-nephrectomy),

Study Arms (4)

Clear-cell RCC

Participants with clear-cell RCC

Other: Proteomic profiling of urinary EVs; Procedure: Blood sample collection

Papillary RCC

Participants with papillary RCC

Other: Proteomic profiling of urinary EVs; Procedure: Blood sample collection

Chromophobe RCC

Participants with chromophobe RCC

Other: Proteomic profiling of urinary EVs; Procedure: Blood sample collection

Benign Renal Tumor

Participants with benign renal tumors

Other: Proteomic profiling of urinary EVs

Interventions

Blood sample collection PROCEDURE

Blood samples collected pre- and post-nephrectomy

Chromophobe RCC; Clear-cell RCC; Papillary RCC

Proteomic profiling of urinary EVs OTHER

EV isolation and mass spectrometry.

Benign Renal Tumor; Chromophobe RCC; Clear-cell RCC; Papillary RCC

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Mayo Clinic patients scheduled to undergo nephrectomy for treatment of RCC.

You may qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Fabrice Lucien-Matteoni, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 21, 2025
• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)