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

Colorectal Carcinoma Clinical Trial

Official title:

The Ohio State University Guardant Shield™ Colorectal Cancer Screening Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05716477
• Other study ID #: OSU-22204
• Secondary ID: NCI-2023-00078
• Status: Recruiting
• Start date: December 23, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: The Ohio State University Comprehensive Cancer Center
• Phone: 800-293-5066
• Email: OSUCCCClinicaltrials[@]osumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

Procedure:
• Biospecimen Collection
Undergo blood sample collection

Other:
• Survey Administration
Complete survey

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	Guardant Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients consented	The number and percentage of patients consented out of those approached to be summarized.	Up to 2 years
Primary	Percentage of patients consented	The number and percentage of patients consented out of those approached to be summarized.	Up to 2 years
Primary	Knowledge about colorectal screening	Summary statistics and data graphics (boxplots, scatterplots, lattice plots) will summarize data about colorectal screening from overall sample and will be correlated with patient demographics using appropriate statistical tests depending on the nature of the data (correlations, t-tests, chi-squared tests, etc.).	Up to 2 years
Primary	Attitudes about colorectal screening	Summary statistics and data graphics (boxplots, scatterplots, lattice plots) will summarize data about colorectal screening from overall sample and will be correlated with patient demographics using appropriate statistical tests depending on the nature of the data (correlations, t-tests, chi-squared tests, etc.).	Up to 2 years
Primary	Beliefs about colorectal screening	Summary statistics and data graphics (boxplots, scatterplots, lattice plots) will summarize data about colorectal screening from overall sample and will be correlated with patient demographics using appropriate statistical tests depending on the nature of the data (correlations, t-tests, chi-squared tests, etc.).	Up to 2 years

External Links

•   The Jamesline