RecruitingNCT06880055

Shield Post-Approval Study Protocol

Sponsor

Guardant Health, Inc.

Enrollment

3,375 participants

Start Date

Jul 14, 2025

Study Type

OBSERVATIONAL

Conditions

Colo-rectal Cancer

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.

Eligibility

Min Age: 45 YearsMax Age: 81 Years

Plain Language Summary

Simplified for easier understanding

This post-approval study monitors the real-world performance of the Shield blood test — a non-invasive colorectal cancer (CRC) screening test done with a blood draw instead of a colonoscopy. The study tracks how the test performs in everyday clinical practice outside of a controlled trial setting. **You may be eligible if:** - You are between 45 and 81 years old - Your doctor has ordered a Shield blood test as part of your routine care - You are considered "average risk" for colorectal cancer (no personal or family history of CRC, no prior polyps, no inflammatory bowel disease) **You may NOT be eligible if:** - You are considered high risk for colorectal cancer (family history, prior polyps, inflammatory bowel disease, genetic syndromes like Lynch syndrome) - You are outside the 45–81 age range - You are already enrolled in another colorectal cancer screening study - You are symptomatic for colorectal cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTShield Blood Test for colo-rectal cancer Screening

Shield Blood Test for colo-rectal cancer Screening

Locations(56)

Southeast Valley Gastroenterology Consultants

Chandler, Arizona, United States

Southeast Valley Gastroenterology Consultants

Gilbert, Arizona, United States

Alliance Research Institute, LLC

Canoga Park, California, United States

Paragon Rx Clinical, Inc.

Garden Grove, California, United States

Amicis Research Center

Granada Hills, California, United States

Desert Oasis Healthcare Medical Group

Palm Springs, California, United States

Digestive Disease Associates

Branford, Connecticut, United States

Digestive Disease Associates

Branford, Connecticut, United States

Gastroenterology Consultants of Boca Raton, LLC

Boca Raton, Florida, United States

Physicians Group of South Florida

North Miami, Florida, United States

Digestive Disease Consultants

Bourbonnais, Illinois, United States

Digestive Disease Consultants

Bourbonnais, Illinois, United States

Christie Clinic

Champaign, Illinois, United States

Christie Clinic

Champaign, Illinois, United States

GI Solutions of Illinois

Chicago, Illinois, United States

GI Solutions of Illinois

Chicago, Illinois, United States

Digestive Health Services

Downers Grove, Illinois, United States

Digestive Health Services

Downers Grove, Illinois, United States

Gastroenterology and Internal Medicine Specialists (GAIMS)

Lake Barrington, Illinois, United States

Gastroenterology and Internal Medicine Specialists (GAIMS)

Lake Barrington, Illinois, United States

Northshore Center for Gastroenterology (NCG)

Libertyville, Illinois, United States

Southwest Gastroenterology (SWG)

Oak Lawn, Illinois, United States

Southwest Gastroenterology (SWG)

Oak Lawn, Illinois, United States

Hutchinson Clinic

Hutchinson, Kansas, United States

Northlake Gastroenterology Associates

Covington, Louisiana, United States

Northlake Gastroenterology Associates

Hammond, Louisiana, United States

Gastroenterology Associates of New Jersey, LLC

Clifton, New Jersey, United States

Gastroenterology Associates of New Jersey

Hackensack, New Jersey, United States

Gastroenterology Associates of New Jersey, LLC

Montclair, New Jersey, United States

Gastroenterology Associates of New Jersey, LLC

Ridgewood, New Jersey, United States

Gastroenterology Associates of New Jersey, LLC

Wayne, New Jersey, United States

Gastroenterology Associates of New Jersey

Wayne, New Jersey, United States

Associated Gastroenterologists of Central New York

Camillus, New York, United States

Syracuse Gastroenterological Associates, P.C.

East Syracuse, New York, United States

Associated Gastroenterologists of Central New York

Fayetteville, New York, United States

Orchard Park Family Practice

Orchard Park, New York, United States

GastroCare LI

Valley Stream, New York, United States

GastroCare LI

Valley Stream, New York, United States

Cary Gastroenterology Associates

Cary, North Carolina, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

University of North Carolina at Chapel Hill

Hillsborough, North Carolina, United States

Piedmont Healthcare, P.A.

Mocksville, North Carolina, United States

Pinehurst Medical Clinic

Pinehurst, North Carolina, United States

Sanford Cardiology Pinehurst Medical Clinic

Sanford, North Carolina, United States

Piedmont Healthcare LLC

Statesville, North Carolina, United States

US Digestive Health at Blair

Altoona, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Health Living at Pottstown Medical Specialists, Inc

Pottstown, Pennsylvania, United States

Premier Family Physicians

Austin, Texas, United States

Premier Family Physicians

Austin, Texas, United States

Integrity Advanced Therapeutics, PLLC

Houston, Texas, United States

Center for Digestive Disease

Shenandoah, Texas, United States

Horizon Clinical Research Group

Tomball, Texas, United States

Horizon Clinical Research Group

Tomball, Texas, United States

Tidewater Physician Multispecialty Group Clinical Research

Williamsburg, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06880055

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