Disease Burden and Biology Using Tumor Cell Free DNA in Metastatic Kidney Cancer

NCT04883827 | Completed

• 1 other identifier: VICC URO 2144
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 3

Brief Summary

This study will assess whether DNA released by kidney cancer into the blood stream and urine of patients can be used to monitor tumor burden and tumor response to treatment in patients receiving immunotherapy

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Evaluate tumor cfDNA as a dynamic marker of response to IO therapy

  Measure of changes in the amount of tumor DNA correlated with result of routine tumor imaging studies

  Up to about 2 years

Study Arms (2)

RCC with clear cell component

Other: Blood collection; Other: Urine collection

Healthy Volunteer (no longer recruiting)

Other: Blood collection; Other: Urine collection

Interventions

Blood collection OTHER

20-40 mL of blood to extract cell free DNA

Healthy Volunteer (no longer recruiting); RCC with clear cell component

Urine collection OTHER

up to 15 mL of urine to extract cell free DNA

Healthy Volunteer (no longer recruiting); RCC with clear cell component

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (18 year or older) with Renal Cell Carcinoma with clear cell component and receiving an IO-containing regimen or healthy volunteers (18 years or older)

You may qualify if:

• Renal Cell Carcinoma with clear cell component
• Stage IV
• Receiving IO-containing regimen
• Measurable disease per RECIST 1.1

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• United States Department of Defense: collaborator

Study Sites (3)

Tennessee Valley Health Care System

Nashville, Tennessee, 37212, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Blood Specimen Collection; Urine Specimen Collection

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Scott Haake, MD

  Vanderbilt Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 12, 2021
• Study Start: January 6, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

US (3)