Shield Post-Approval Study Protocol
Guardant Health, Inc.
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.
Description
Colorectal cancer (CRC) is the fourth most diagnosed cancer and second leading cause of cancer-related death in the US, with an estimated 53,010 deaths attributable to CRC in 2024. The risk of CRC increases with age, with the majority of cases and deaths occurring in individuals aged 65 years or older. While the incidence of CRC in Americans 65 years of age or older has decreased over the last decade, the incidence of CRC in younger Americans aged 55 years or younger has been increasing since the mid-1990s. CRC disproportionately affects minority populations, with American Indian/Alaska Native…
Eligibility
- Age range
- 45–81 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- Diagnostic TestShield Blood Test for colo-rectal cancer Screening
Shield Blood Test for colo-rectal cancer Screening
Locations (56)
- Southeast Valley Gastroenterology ConsultantsChandler, Arizona
- Southeast Valley Gastroenterology ConsultantsGilbert, Arizona
- Alliance Research Institute, LLCCanoga Park, California
- Paragon Rx Clinical, Inc.Garden Grove, California
- Amicis Research CenterGranada Hills, California
- Desert Oasis Healthcare Medical GroupPalm Springs, California