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

September 14, 2023 updated by: Scott Haake, MD, Vanderbilt-Ingram Cancer Center

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Vanderbilt-Ingram Service for Timely Access
  • Phone Number: 800-811-8480
  • Email: cip@vumc.org

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • Principal Investigator:
          • Scott Haake, MD
        • Contact:
          • Vanderbilt-Ingram Service for Timely Access
          • Phone Number: 800-811-8480
          • Email: cip@vumc.org
      • Nashville, Tennessee, United States, 37212
        • Recruiting
        • Tennessee Valley Health Care System
        • Contact:
        • Principal Investigator:
          • Scott Haake, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Eric Jonasch, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults (18 year or older) with Renal Cell Carcinoma with clear cell component and receiving an IO-containing regimen or healthy volunteers (18 years or older)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RCC with clear cell component
Other: Blood collection
20-40 mL of blood to extract cell free DNA
Other: Urine collection
up to 15 mL of urine to extract cell free DNA
Healthy Volunteer (no longer recruiting)
Other: Blood collection
20-40 mL of blood to extract cell free DNA
Other: Urine collection
up to 15 mL of urine to extract cell free DNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate tumor cfDNA as a dynamic marker of response to IO therapy
Time Frame: Up to about 2 years
Measure of changes in the amount of tumor DNA correlated with result of routine tumor imaging studies
Up to about 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Scott Haake, MD, Vanderbilt Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2021

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

May 6, 2021

First Submitted That Met QC Criteria

May 6, 2021

First Posted (Actual)

May 12, 2021

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC URO 2144

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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