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

NCT05716477 | Completed DMC

• 2 other identifiers: OSU-22204NCI-2023-00078
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Colorectal Carcinoma

Outcome Measures

Primary Outcomes (5)

• Number of patients consented

  The number and percentage of patients consented out of those approached to be summarized.

  Up to 2 years

• Percentage of patients consented

  The number and percentage of patients consented out of those approached to be summarized.

  Up to 2 years

• 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

• 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

• 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

Study Arms (1)

Screening (biospecimen collection)

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

Procedure: Biospecimen Collection; Other: Survey Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Screening (biospecimen collection)

Survey Administration OTHER

Complete survey

Screening (biospecimen collection)

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• Guardant Health, Inc.: collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Electra D Paskett, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: February 8, 2023
• Study Start: December 23, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: January 9, 2025

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)