500
Participants
Start Date
February 9, 2023
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2025
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.
RECRUITING
PCC Community Wellness Center, Chicago
Milton S. Hershey Medical Center
OTHER