Disease Burden and Biology Using Tumor Cell Free DNA in Metastatic Kidney Cancer
Purpose
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
Condition
- Renal Cell Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts 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 (exclusion criteria only for healthy patient cohort)
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| RCC with clear cell component |
|
|
| Healthy Volunteer (no longer recruiting) |
|
Recruiting Locations
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Tennessee Valley Health Care System
Nashville, Tennessee 37212
Nashville, Tennessee 37212
More Details
- Status
- Recruiting
- Sponsor
- Vanderbilt-Ingram Cancer Center
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