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

Not yet recruiting

• Conditions: Renal Cell Carcinoma; Clear-cell Renal Cell Carcinoma; Papillary Renal Cell Carcinoma; Chromophobe Renal Cell Carcinoma; Kidney Cancer

• Registration Number: NCT07243067
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-14
• Study First Submitted QC: 2025-11-19
• Last Update Submitted: 2025-11-19
• Study First Posted: 2025-11-21
• Last Update Posted: 2025-11-21
• Study Start: 2026-01-15
• Primary Completion: 2026-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differentiate tumor-derived extracellular vesicle (tdEV) surface proteins expressed in benign vs malignant renal tumors	Baseline	Differential protein expression analysis will be performed on median-normalized values using a t test with Benjamini-Hochberg correction at a false discovery rate of 1%. We will create a composite score to prioritize tdEV proteins significantly upregulated and highly expressed in each RCC subtype versus benign. To identify high confidence markers, we will select markers that are also found upregulated at the tissue level using published proteomic datasets of RCC and normal tissue. To validate the specificity of RCC markers, we will test the diagnostic performance (AUC, sensitivity and specificity) of urinary tdEVs signatures by analyzing a separate cohort of \~200 patients with pathologically confirmed benign renal masses and RCC.
Prediction of metastasis after surgery	Perioperative (pre- and post-nephrectomy),	Association of tdEV levels will be correlated with clinicopathological features using two-sided Mann-Whitney U tests (for categorical variables) and Spearman/Pearson correlations (for continuous variables such as tumor size). Kaplan-Meier estimates for metastasis free survival across quartiles of pre-operative and post-operative tdEV expression will be compared. Multivariable Cox proportional hazard models will be constructed for metastasis to test if tdEV levels (both pre- and post-nephrectomy) can improve the diagnostic performance (AUC) of known clinical and pathologic risk stratification models.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States