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

Vanderbilt-Ingram Cancer Center180 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

180

Conditions

Renal Cell Carcinoma

Interventions

Blood collectionOTHER

20-40 mL of blood to extract cell free DNA

Urine collectionOTHER

up to 15 mL of urine to extract cell free DNA

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (3)

Tennessee Valley Health Care System

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

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

Time frame: Up to about 2 years

Data from ClinicalTrials.gov

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