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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07243067
Enrollment
300
Registered
2025-11-21
Start date
2026-07-15
Completion date
2027-04-30
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERProteomic profiling of urinary EVs

EV isolation and mass spectrometry.

PROCEDUREBlood sample collection

Blood samples collected pre- and post-nephrectomy

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Differentiate tumor-derived extracellular vesicle (tdEV) surface proteins expressed in benign vs malignant renal tumorsBaselineDifferential 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.

Countries

United States

Contacts

CONTACTClinical Trials Referral Office
mayocliniccancerstudies@mayo.edu855-776-0015
PRINCIPAL_INVESTIGATORFabrice Lucien-Matteoni, MD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026