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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Urine sample in existing biorepository

High-risk renal cell carcinoma (RCC) per American Urological Association (AUA) guidelines

Scheduled to undergo nephrectomy

Disqualifiers

Does not meet inclusion criteria

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Proteomic profiling of urinary EVs

    Other intervention

    EV isolation and mass spectrometry.

  • Blood sample collection

    Procedure/Surgery

    Blood samples collected pre- and post-nephrectomy

Treatment groups

300 Participants
are divided into 4 treatment groups
Group A: Clear-cell RCC2 interventions
Group B: Papillary RCC2 interventions
Group C: Chromophobe RCC2 interventions
Group D: Benign Renal Tumor1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
Perioperative (pre- and post-nephrectomy),

Secondary outcomes

Other outcomes

Sponsors and contacts

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