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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

146 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-23

Study Completion Date

2024-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Colorectal Cancer Screening Options

NCT05987709

Colon Cancer

COMPLETED NA

Understanding Patient Preference on Colorectal Cancer Screening Options

NCT05536713

Colorectal Cancer

RECRUITING

Shield Post-Approval Study Protocol

NCT06880055

Colo-rectal Cancer

RECRUITING

Colonoscopy or Fecal Occult Blood Test in Screening Healthy Participants for Colorectal Cancer

NCT00102011

Colorectal Cancer

ACTIVE_NOT_RECRUITING PHASE3

Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold

NCT03821948

Colorectal Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Screening (biospecimen collection)

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

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Survey Administration

Intervention Type OTHER

Complete survey

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biospecimen Collection

Undergo blood sample collection

Intervention Type PROCEDURE

Survey Administration

Complete survey

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Biological Sample Collection Biospecimen Collected Specimen Collection

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes