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Shield Post-Approval Study Protocol

NCT06880055 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3375

Last updated 2026-03-19

No results posted yet for this study

Summary

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.

Conditions

  • Colo-rectal Cancer

Interventions

DIAGNOSTIC_TEST

Shield Blood Test for colo-rectal cancer Screening

Shield Blood Test for colo-rectal cancer Screening

Sponsors & Collaborators

  • Guardant Health, Inc.

    lead INDUSTRY

Eligibility

Min Age
45 Years
Max Age
81 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-14
Primary Completion
2030-09-01
Completion
2030-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06880055 on ClinicalTrials.gov