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

February 24, 2026 updated by: Mayo Clinic
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester
        • Contact:
        • Principal Investigator:
          • Fabrice Lucien-Matteoni, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Clear-cell RCC
Participants with clear-cell RCC
Other: Proteomic profiling of urinary EVs
EV isolation and mass spectrometry.
Procedure: Blood sample collection
Blood samples collected pre- and post-nephrectomy
Papillary RCC
Participants with papillary RCC
Other: Proteomic profiling of urinary EVs
EV isolation and mass spectrometry.
Procedure: Blood sample collection
Blood samples collected pre- and post-nephrectomy
Chromophobe RCC
Participants with chromophobe RCC
Other: Proteomic profiling of urinary EVs
EV isolation and mass spectrometry.
Procedure: Blood sample collection
Blood samples collected pre- and post-nephrectomy
Benign Renal Tumor
Participants with benign renal tumors
Other: Proteomic profiling of urinary EVs
EV isolation and mass spectrometry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Perioperative (pre- and post-nephrectomy),

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Fabrice Lucien-Matteoni, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-003121
  • HT9425-25-1-0607 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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