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

NCT ID: NCT07243067

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-15

Study Completion Date

2026-11-30

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Clear-cell RCC

Participants with clear-cell RCC

Proteomic profiling of urinary EVs

Intervention Type OTHER

EV isolation and mass spectrometry.

Blood sample collection

Intervention Type PROCEDURE

Blood samples collected pre- and post-nephrectomy

Papillary RCC

Participants with papillary RCC

Proteomic profiling of urinary EVs

Intervention Type OTHER

EV isolation and mass spectrometry.

Blood sample collection

Intervention Type PROCEDURE

Blood samples collected pre- and post-nephrectomy

Chromophobe RCC

Participants with chromophobe RCC

Proteomic profiling of urinary EVs

Intervention Type OTHER

EV isolation and mass spectrometry.

Blood sample collection

Intervention Type PROCEDURE

Blood samples collected pre- and post-nephrectomy

Benign Renal Tumor

Participants with benign renal tumors

Proteomic profiling of urinary EVs

Intervention Type OTHER

EV isolation and mass spectrometry.

Interventions

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Proteomic profiling of urinary EVs

EV isolation and mass spectrometry.

Intervention Type OTHER

Blood sample collection

Blood samples collected pre- and post-nephrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Urine sample in existing biorepository
* High-risk renal cell carcinoma (RCC) per American Urological Association (AUA) guidelines
* Scheduled to undergo nephrectomy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabrice Lucien-Matteoni, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Central Contacts

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Clinical Trials Referral Office

Role: CONTACT

855-776-0015

Facility Contacts

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Clinical Trials Referral Office

Role: primary

855-776-0015

Other Identifiers

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HT9425-25-1-0607

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

25-003121

Identifier Type: -

Identifier Source: org_study_id

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