Shield Post-Approval Study Protocol

Conditions

• Colo-rectal Cancer

Eligibility Criteria

Sex

ALL

Age

45 Years - 81 Years

Healthy Volunteers

Accepted

Interventions

• Shield Blood Test for colo-rectal cancer Screening — DIAGNOSTIC_TEST
  Shield Blood Test for colo-rectal cancer Screening

Study Details

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.

Key Dates

Start date

Jul 14, 2025

Status verified

Dec 2025

Primary completion

Sep 1, 2030

Completion

Dec 1, 2030

Study Design

Enrollment

3,375 participants (estimated)

Arms

• Arm: Enrolled Subjects
  Subjects age 45 to 81 at average risk of CRC who meet inclusion, do not meet exclusion criteria, and who successfully enroll in the study.

Primary Outcome Measure

Performance measures of the Shield test will be assessed for the second testing interval [ Time Frame: 33-42 Months Post-Enrollment ]

Central Contacts

• Hannah Oakley
  415-307-2774
  [email protected]

Locations (56)

Find similar trials in Chandler, AZ

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