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

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

Completed

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tennessee Valley Health Care System, Nashville, Tennessee, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood collection

Other

20-40 mL of blood to extract cell free DNA

Urine collection

Other

up to 15 mL of urine to extract cell free DNA

Primary outcomes

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

Time frame: Up to about 2 years

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

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

United States Department of Defense

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: May 12, 2021
Registry last updated: Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed