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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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The Ohio State University Guardant Shield™ Colorectal Cancer Screening Project

Conditions
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Colorectal Carcinoma

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Screening (biospecimen collection)<br>Participants undergo blood specimen collection and complete survey on study. Participants may optionally undergo standard of care FIT testing on study. | Procedure: Biospecimen Collection<br>* Undergo blood sample collection<br>* Other names: Specimen Collection;Other: Survey Administration<br>* Complete survey<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |