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

Completed

• Conditions: Renal Cell Carcinoma
• Interventions: Other: Blood collection; Other: Urine collection

• Registration Number: NCT04883827
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

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

Detailed 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

Study Timeline

• Study Start: 2021-01-06
• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-12
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RCC with clear cell component	Urine collection	-
Healthy Volunteer (no longer recruiting)	Urine collection	-
RCC with clear cell component	Blood collection	-
Healthy Volunteer (no longer recruiting)	Blood collection	-

Primary Outcome Measures

Name	Time	Method
Evaluate tumor cfDNA as a dynamic marker of response to IO therapy	Up to about 2 years	Measure of changes in the amount of tumor DNA correlated with result of routine tumor imaging studies

Trial Locations

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