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RECRUITING

NCT06880055

Shield Post-Approval Study Protocol

Sponsor: Guardant Health, Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

45 Years - 81 Years

Study Type

OBSERVATIONAL

Enrollment

3375

Start Date

2025-07-14

Completion Date

2030-12-01

Last Updated

2026-03-19

Healthy Volunteers

Yes

Conditions

Colo-rectal Cancer

Interventions

DIAGNOSTIC_TEST

Shield Blood Test for colo-rectal cancer Screening

Inclusion Criteria: 1. Subjects aged 45-81 years at time of consent 2. Intending to undergo a standard of care Shield test 3. Considered by a physician or healthcare provider as being of 'average risk' for CRC; 'Average-risk' individuals in the context of CRC screening are defined as those who do not have symptoms of CRC and do not have increased risk factors for the disease (i.e., prior diagnosis of CRC, adenomatous polyps, or inflammatory bowel disease; family history of CRC or known hereditary predisposition to CRC). 4. Subject agrees to comply with study procedures and associated standard of care assessments. Exclusion Criteria: 1. Undergoing colonoscopy for investigation of symptoms 2. Personal history of colorectal cancer (CRC), adenomas, or other related cancers 3. Family history of CRC, defined as having one or more first-degree relative (parent, sibling, or child) diagnosed with CRC at any age 4. Positive result on another colorectal cancer screening method within the last six months, or: * 12 months for fecal occult blood test (FOBT) or fecal immunochemical test (FIT) * 36 months for FIT-DNA test 5. Personal history of any of the following high-risk conditions for colorectal cancer: * Inflammatory Bowel Disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease * Familial adenomatous polyposis (FAP) * Other hereditary cancer syndromes including but not limited to: * Hereditary non-polyposis colorectal cancer syndrome (HNPCC) or "Lynch Syndrome", Peutz- Jeghers Syndrome, MUTYH Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis 6. Positive Shield test result within the previous 3 years 7. History of any malignancy (patients who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study) 8. Known diagnosis of inflammatory bowel disease 9. Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs (DMARDs) 10. Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent 11. Known medical condition which, in the opinion of the Investigator, should preclude enrollment into the study 12. Participation in a clinical research study in which an experimental medication has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of colonoscopy

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

Clinical Research Directory

Shield Post-Approval Study Protocol

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (56)