This study assesses 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. Studying samples of blood and urine from patients with kidney cancer that has spread to other places in the body (metastatic) in the laboratory may help doctors predict how well patients will respond to treatment.
Additional locations may be listed on ClinicalTrials.gov for NCT04883827.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. Evaluate tumor cell free deoxyribonucleic acid (cfDNA) as a dynamic marker of response to immuno-oncology (IO) therapy.
OUTLINE:
Patients undergo collection of blood and urine samples at baseline, at first restaging scan (2-4 months), second restaging scan (4-8 months), and at time of progression or approximately 2 years (22-26 months), whichever occurs first. Healthy controls undergo collection of blood and urine samples at baseline.
Trial PhaseNo phase specified
Trial Typebasic science
Lead OrganizationVanderbilt University/Ingram Cancer Center
Principal InvestigatorScott Haake