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

Vanderbilt University Medical Center

Status: Completed

Conditions: Renal Cell Carcinoma

Treatments: Other: Blood collection; Other: Urine collection

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04883827

VICC URO 2144

Details and patient eligibility

About

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

Full 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

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

180 participants in 2 patient groups

RCC with clear cell component

Treatment:

Other: Urine collection

Other: Blood collection

Healthy Volunteer (no longer recruiting)

Treatment:

Other: Urine collection

Other: Blood collection