Skip to main content
OpenTrials
Completed

NCT Number: NCT05716477

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Carcinoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

45 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo blood sample collection

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Survey Administration

Other

Complete survey

Primary outcomes

  1. Number of patients consented

    Time frame: Up to 2 years

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

  2. Percentage of patients consented

    Time frame: Up to 2 years

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

  3. Knowledge about colorectal screening

    Time frame: Up to 2 years

    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.).

  4. Attitudes about colorectal screening

    Time frame: Up to 2 years

    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.).

  5. Beliefs about colorectal screening

    Time frame: Up to 2 years

    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.).

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • Guardant Health, Inc.

Registry information

Official study title

The Ohio State University Guardant Shield™ Colorectal Cancer Screening Project

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 8, 2023
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.