Understanding Patient Preference on Colorectal Cancer Screening Options

RecruitingOBSERVATIONAL
Enrollment

500

Participants

Timeline

Start Date

February 9, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Colorectal Cancer
Interventions
DEVICE

Guardant SHIELD blood-based colorectal cancer screening test

The Guardant SHIELD test combines a next-generation sequencing (NGS) based assay and a protein assay for the qualitative detection of colorectal cancer-derived tumor signal in the blood of patients at average risk for CRC. The Guardant SHIELD was developed at Guardant Health's clinical laboratory, a certified laboratory under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), to perform high-complexity clinical laboratory testing. The test has not been cleared or approved by the U.S. Food and Drug Administration (FDA); however, its performance has been established through a clinical trial, the ECLIPSE study (ClinicalTrials.gov Identifier: NCT04136002). The ECLIPSE clinical trial was a prospective, multi-site registration study and reached the targeted enrollment of 12,750 patients in December 2021.

Trial Locations (1)

60302

RECRUITING

PCC Community Wellness Center, Chicago

All Listed Sponsors
lead

Milton S. Hershey Medical Center

OTHER