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

The Ohio State University

Status: Completed

Conditions: Colorectal Carcinoma

Treatments: Procedure: Biospecimen Collection; Other: Survey Administration

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05716477

NCI-2023-00078 (Registry Identifier)

OSU-22204

Details and patient eligibility

About

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).

Full 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.

Enrollment: 146 patients

Sex: Female

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

146 participants in 1 patient group

Screening (biospecimen collection)

Description:

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

Treatment:

Other: Survey Administration

Procedure: Biospecimen Collection