Shield Post-Approval Study Protocol

The Shield post-approval study (PAS) is a prospective, longitudinal study supplemented with Real World Evidence (RWE) to evaluate the longitudinal performance of Shield in an average risk population at a second round of testing for individuals between the ages of 45 and 81 at average risk of CRC using colonoscopy as the reference method.

NCT Number	NCT06880055
Lead Sponsor	Guardant Health, Inc.
Conditions	Colo-rectal Cancer
Enrollment	3,375 participants
Start Date	2025-07-14
Primary Completion	2030-09-01 (estimated)
Study Completion	2030-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-07