Shield Post-Approval Study Protocol
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 th
| Condition(s) | Colo-rectal Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 |
| Ages | 45 Years to 81 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Guardant Health, Inc. |
| Locations | Chandler, Arizona, United States; Gilbert, Arizona, United States; Canoga Park, California, United States; Garden Grove, California, United States; Granada Hills, California, United States; Palm Springs, California, United States (+50 more sites) |
| Start date | 2025-07-14 |
| NCT ID | NCT06880055 |
| Official listing | https://clinicaltrials.gov/study/NCT06880055 |