Observational Study for Kidney Cancer Classification

This study is looking for better ways to tell the difference between benign (non-cancerous) and malignant (cancerous) kidney tumors, and to predict if kidney cancer will spread after surgery. Researchers are studying proteins found in tiny particles called extracellular vesicles (EVs) from urine, and also collecting blood samples before and after kidney removal surgery (nephrectomy). This study is for people with high-risk kidney cancer who are scheduled for nephrectomy and have a urine sample already stored in a biorepository. The goal is to find protein markers that could lead to new, non-invasive tests for kidney cancer.

Study design
This is an observational study aiming to enroll 300 participants. It is a correlative (lab-based) study.
What's involved
You would provide blood samples before and after your nephrectomy. Urine samples from an existing collection will also be used.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes at baseline and around the time of surgery (pre- and post-nephrectomy).

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NCT07243067

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

Not Yet Recruiting
Not specifiedAll AgesObservational
Mayo Clinic
~300 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:Proteomic profiling of urinary EVsBlood sample collection

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Differentiate tumor-derived extracellular vesicle (tdEV) surface proteins expressed in benign vs malignant renal tumors
Measured over Baseline
+1 more outcome measured
Renal Cell Carcinoma
Clear-cell Renal Cell Carcinoma
Papillary Renal Cell Carcinoma
Chromophobe Renal Cell Carcinoma
Kidney Cancer
1 sites across 1 states
Minnesota1
  • Fabrice Lucien-Matteoni, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Eligibility criteria

Inclusion

Urine sample in existing biorepository
High-risk renal cell carcinoma (RCC) per American Urological Association (AUA) guidelines
Scheduled to undergo nephrectomy
  • Differentiate tumor-derived extracellular vesicle (tdEV) surface proteins expressed in benign vs malignant renal tumorsBaseline

    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 surgeryPerioperative (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.