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Trial Title:
Blood Test (Guardant Shield™) for Screening of Colorectal Cancer in Underserved Patients
NCT ID:
NCT05716477
Condition:
Colorectal Carcinoma
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Screening (biospecimen collection)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Complete survey
Arm group label:
Screening (biospecimen collection)
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).
Detailed 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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
Female
Minimum age:
45 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Electra D. Paskett, PhD
Phone:
614-293-3917
Email:
electra.paskett@osumc.edu
Investigator:
Last name:
Electra D. Paskett, PhD
Email:
Principal Investigator
Start date:
December 23, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Ohio State University Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
Guardant Health, Inc.
Agency class:
Industry
Source:
Ohio State University Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05716477
http://cancer.osu.edu
