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

NCT ID: NCT04883827

Last Updated: 2024-10-22

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-06

Study Completion Date

2023-12-01

Brief Summary

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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

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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

Conditions

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Renal Cell Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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RCC with clear cell component

Blood collection

Intervention Type OTHER

20-40 mL of blood to extract cell free DNA

Urine collection

Intervention Type OTHER

up to 15 mL of urine to extract cell free DNA

Healthy Volunteer (no longer recruiting)

Blood collection

Intervention Type OTHER

20-40 mL of blood to extract cell free DNA

Urine collection

Intervention Type OTHER

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

Intervention Type OTHER

Urine collection

up to 15 mL of urine to extract cell free DNA

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Renal Cell Carcinoma with clear cell component
* Stage IV
* Receiving IO-containing regimen
* Measurable disease per RECIST 1.1
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Scott Haake, MD

Principal Investigator

Responsibility Role 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

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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VICC URO 2144

Identifier Type: -

Identifier Source: org_study_id

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