Blood Test (Guardant Shield™) for Screening of Colorectal Cancer in Underserved Patients

Last updated: January 7, 2025
Sponsor: Ohio State University Comprehensive Cancer Center
Overall Status: Completed

Phase

N/A

Condition

Cancer/tumors

Colorectal Cancer

Carcinoma

Treatment

Survey Administration

Biospecimen Collection

Clinical Study ID

NCT05716477
OSU-22204
NCI-2023-00078
  • Ages > 45
  • Female
  • Accepts Healthy Volunteers

Study Summary

This clinical trial evaluates the use of a blood test (Guardant Shield™) for colorectal cancer screening. Colorectal cancer is the third leading cancer and cause of death in the United States. Screening may help doctors find colorectal cancer early when it is easier to treat yet nearly a third of all people eligible for screening have never had a screening test performed. Currently, doctors use a stool- based test such as the fecal immunochemical test (FIT) and visual tests such as a colonoscopy. Blood based testing such as Guardant Shield™, may provide a quick and effective way to screen patients that are hard to reach or with limited access (underserved).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women aged 45 years of age and older who are in need of colorectal screening

  • Do not have a history of cancer

  • Able to read and understand English

  • Have a provider to receive the results of the test and who will follow-up test results

  • Able to provide informed consent

Study Design

Total Participants: 146
Treatment Group(s): 2
Primary Treatment: Survey Administration
Phase:
Study Start date:
December 23, 2022
Estimated Completion Date:
November 30, 2024

Study Description

PRIMARY OBJECTIVES:

I. Recruit women age 45 years and older who are in need of colorectal cancer screening from minority and underserved populations via a community mammography van.

II. Obtain data regarding knowledge, attitudes and beliefs about colorectal cancer screening.

OUTLINE:

Participants undergo blood specimen collection and complete survey on study. Participants may optionally undergo standard of care FIT testing on study.

Connect with a study center

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210
    United States

    Site Not Available

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