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NCT04883827 Clinical Trial

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

Renal Cell Carcinoma Clinical Trial

Official title:
Monitoring Disease Burden and Biology Using Tumor Cell Free DNA in Metastatic Kidney Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04883827
Other study ID # VICC URO 2144
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 6, 2021
Est. completion date February 2026

Study information
Verified date September 2023
Source Vanderbilt-Ingram Cancer Center
Contact Scott Haake, MD
Phone 615-936-8422
Email scott.haake@vumc.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Description:

Primary Objective: - Evaluate tumor cell free (cf)DNA as a dynamic marker of response to immuno-oncology (IO) therapy Exploratory Objective: - Collect data on somatic mutations in cfDNA to gain insight into the biology of IO-responders and -non-responders

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date February 2026
Est. primary completion date February 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Renal Cell Carcinoma with clear cell component - Stage IV - Receiving IO-containing regimen - Measurable disease per RECIST 1.1 Exclusion Criteria: - Active cancer (exclusion criteria only for healthy patient cohort)

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Blood collection
20-40 mL of blood to extract cell free DNA
• Urine collection
up to 15 mL of urine to extract cell free DNA

Locations
Country Name City State
United States The University of Texas MD Anderson Cancer Center Houston Texas
United States Tennessee Valley Health Care System Nashville Tennessee
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (2)
Lead Sponsor Collaborator
Vanderbilt-Ingram Cancer Center United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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