| NCT ID | NCT06880055 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guardant Health, Inc. |
| Condition | Colo-rectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,375 participants |
| Start Date | 2025-07-14 |
| Primary Completion | 2030-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,375 participants in total. It began in 2025-07-14 with a primary completion date of 2030-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06880055 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 81 Years, studying Colo-rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06880055 currently recruiting?
Yes, NCT06880055 is actively recruiting participants. Contact the research team at solar@guardanthealth.com for enrollment information.
Where is the NCT06880055 trial being conducted?
This trial is being conducted at Chandler, United States, Gilbert, United States, Canoga Park, United States, Garden Grove, United States and 11 additional locations.
Who is sponsoring the NCT06880055 clinical trial?
NCT06880055 is sponsored by Guardant Health, Inc.. The trial plans to enroll 3,375 participants.
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