Shield Post-Approval Study Protocol
Recruiting · NCT06880055 · Observational (researchers observe without assigning treatment) · Lead sponsor: Guardant Health, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Shield Blood Test for colo-rectal cancer Screening
What this trial is about
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.
Who can take part
Age range
45 Years to 81 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Subjects aged 45-81 years at time of consent
- Intending to undergo a standard of care Shield test
- 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).
- Subject agrees to comply with study procedures and associated standard of care assessments.
Exclusion criteria
- Undergoing colonoscopy for investigation of symptoms
- Personal history of colorectal cancer (CRC), adenomas, or other related cancers
- Family history of CRC, defined as having one or more first-degree relative (parent, sibling, or child) diagnosed with CRC at any age
- 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
- 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
- Positive Shield test result within the previous 3 years
- 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)
- Known diagnosis of inflammatory bowel disease
- Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs (DMARDs)
- 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
- Known medical condition which, in the opinion of the Investigator, should preclude enrollment into the study
- 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
Where it is running
60 locations listed across 15 US states.
- Southeast Valley Gastroenterology Consultants - Chandler, Arizona, United States
- Southeast Valley Gastroenterology Consultants - Gilbert, Arizona, United States
- Elite Primary Physicians, Inc. - Anaheim, California, 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
- Amicis Research Center - Sherman Oaks, California, United States
- Amicis Research Center - Valencia, California, United States
- Coral Clinics - Winnetka, 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
- Manuel Espinel MD PA - Delray Beach, Florida, United States
- Innova Pharma Research, LLC - Doral, Florida, United States
- Marisela Gonzalez, MD - Miami, Florida, United States
- Research Associates of South Florida, LLC - Miami, Florida, United States
- Florida South Research Phase I-IV, Inc. - Miami, Florida, United States
- Physicians Group of South Florida - North Miami, Florida, United States
- NMC Research - Tampa, 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
- Embassy Research Network - Bloomfield Township, Michigan, United States
- Quinn Healthcare, PLLC - Ridgeland, Mississippi, 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
- NYU Langone - New York, 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
Showing 60 of 69 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →