Disease Burden and Biology Using Tumor Cell Free DNA in Metastatic Kidney Cancer
NCT ID: NCT04883827
Last Updated: 2024-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
180 participants
OBSERVATIONAL
2021-01-06
2023-12-01
Brief Summary
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Detailed Description
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\- 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
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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RCC with clear cell component
Blood collection
20-40 mL of blood to extract cell free DNA
Urine collection
up to 15 mL of urine to extract cell free DNA
Healthy Volunteer (no longer recruiting)
Blood collection
20-40 mL of blood to extract cell free DNA
Urine collection
up to 15 mL of urine to extract cell free DNA
Interventions
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Blood collection
20-40 mL of blood to extract cell free DNA
Urine collection
up to 15 mL of urine to extract cell free DNA
Eligibility Criteria
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Inclusion Criteria
* Stage IV
* Receiving IO-containing regimen
* Measurable disease per RECIST 1.1
18 Years
ALL
Yes
Sponsors
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United States Department of Defense
FED
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Scott Haake, MD
Principal Investigator
Principal Investigators
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Scott Haake, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt Medical Center
Locations
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Tennessee Valley Health Care System
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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VICC URO 2144
Identifier Type: -
Identifier Source: org_study_id
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