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Shield Post-Approval Study Protocol

NCT06880055

This study is recruiting at 58 US sites in 14 states, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Colo-rectal Cancer

Eligibility basics and study details

Study type
Observational
Phase
Not applicable
Ages
45 to 81 years
Sex
All
Healthy volunteers
Accepted
Sponsor
Guardant Health, Inc.
Last updated on ClinicalTrials.gov
August 7, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Arizona · 2

  • Southeast Valley Gastroenterology Consultants · Chandler, AZ
  • Southeast Valley Gastroenterology Consultants · Gilbert, AZ

California · 7

  • Elite Primary Physicians, Inc. · Anaheim, CA
  • Alliance Research Institute, LLC · Canoga Park, CA
  • Amicis Research Center · Granada Hills, CA
  • Desert Oasis Healthcare Medical Group · Palm Springs, CA
  • Amicis Research Center · Sherman Oaks, CA
  • Amicis Research Center · Valencia, CA
  • Coral Clinics · Winnetka, CA

Connecticut · 2

  • Digestive Disease Associates · Branford, CT
  • Digestive Disease Associates · Branford, CT

Florida · 8

  • Gastroenterology Consultants of Boca Raton, LLC · Boca Raton, FL
  • Manuel Espinel MD PA · Delray Beach, FL
  • Innova Pharma Research, LLC · Doral, FL
  • Florida South Research Phase I-IV, Inc. · Miami, FL
  • Marisela Gonzalez, MD · Miami, FL
  • Research Associates of South Florida, LLC · Miami, FL
  • Physicians Group of South Florida · North Miami, FL
  • NMC Research · Tampa, FL

Illinois · 12

  • Digestive Disease Consultants · Bourbonnais, IL
  • Digestive Disease Consultants · Bourbonnais, IL
  • Christie Clinic · Champaign, IL
  • GI Solutions of Illinois · Chicago, IL
  • GI Solutions of Illinois · Chicago, IL
  • Digestive Health Services · Downers Grove, IL
  • Digestive Health Services · Downers Grove, IL
  • Gastroenterology and Internal Medicine Specialists (GAIMS) · Lake Barrington, IL
  • Gastroenterology and Internal Medicine Specialists (GAIMS) · Lake Barrington, IL
  • Northshore Center for Gastroenterology (NCG) · Libertyville, IL
  • Southwest Gastroenterology (SWG) · Oak Lawn, IL
  • Southwest Gastroenterology (SWG) · Oak Lawn, IL

Louisiana · 2

  • Northlake Gastroenterology Associates · Covington, LA
  • Northlake Gastroenterology Associates · Hammond, LA

Michigan · 1

  • Embassy Research Network · Bloomfield Township, MI

Mississippi · 1

  • Quinn Healthcare, PLLC · Ridgeland, MS

New Jersey · 4

  • Gastroenterology Associates of New Jersey, LLC · Clifton, NJ
  • Gastroenterology Associates of New Jersey, LLC · Montclair, NJ
  • Gastroenterology Associates of New Jersey, LLC · Ridgewood, NJ
  • Gastroenterology Associates of New Jersey, LLC · Wayne, NJ

New York · 7

  • Associated Gastroenterologists of Central New York · Camillus, NY
  • Syracuse Gastroenterological Associates, P.C. · East Syracuse, NY
  • Associated Gastroenterologists of Central New York · Fayetteville, NY
  • NYU Langone · New York, NY
  • Orchard Park Family Practice · Orchard Park, NY
  • GastroCare LI · Valley Stream, NY
  • GastroCare LI · Valley Stream, NY

North Carolina · 4

  • Cary Gastroenterology Associates · Cary, NC
  • University of North Carolina at Chapel Hill · Chapel Hill, NC
  • University of North Carolina at Chapel Hill · Chapel Hill, NC
  • University of North Carolina at Chapel Hill · Hillsborough, NC

Pennsylvania · 3

  • US Digestive Health at Blair · Altoona, PA
  • University of Pennsylvania · Philadelphia, PA
  • Health Living at Pottstown Medical Specialists, Inc · Pottstown, PA

Texas · 4

  • Integrity Advanced Therapeutics, PLLC · Houston, TX
  • Center for Digestive Disease · Shenandoah, TX
  • Horizon Clinical Research Group · Tomball, TX
  • Horizon Clinical Research Group · Tomball, TX

Virginia · 1

  • Tidewater Physician Multispecialty Group Clinical Research · Williamsburg, VA

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.