Renal Cell Carcinoma
Conditions
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
Interventions
OTHERBlood collection
20-40 mL of blood to extract cell free DNA
OTHERUrine collection
up to 15 mL of urine to extract cell free DNA
Sponsors
United States Department of Defense
Vanderbilt-Ingram Cancer Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 (
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed