Shield Post-Approval Study Protocol

Launched by GUARDANT HEALTH, INC. · Mar 11, 2025

Keywords

ClinConnect Summary

The Shield Post-Approval Study is looking at how well a specific test called the Shield test performs in people who are at average risk for colorectal cancer (CRC). This study will include individuals aged 45 to 81 who are planning to have the Shield test done as part of their regular health check-up. Researchers want to gather real-world information about how effective this test is when used in a larger population during a second round of testing using colonoscopy as a standard method for comparison.

To participate in the study, individuals must be between 45 and 81 years old and considered by their doctor to be at average risk for colorectal cancer. However, certain people cannot join, such as those who have had recent colonoscopies, a history of positive test results for CRC, or certain medical conditions. Participants will need to follow the study guidelines and complete any necessary health assessments. This study is not yet recruiting participants, but it aims to provide valuable insights into the Shield test's effectiveness for detecting colorectal cancer in everyday healthcare settings.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 45-81 years at the 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
• • Subject agrees to comply with study procedures and associated standard of care assessments, as described in Table 2
• Exclusion Criteria:
• • Undergoing colonoscopy for investigation of symptoms
• • Has undergone colonoscopy within preceding 9 years
• • Any history of a positive Shield test result
• • Epi proColon/FIT/FOBT result within the previous 1 year
• • Cologuard result within the previous 3 years
• • History of colorectal cancer
• • History of any malignancy (individuals 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)
• • Positive family history of colorectal cancer, defined as having one or more first-degree relatives (parent, sibling, or child) with CRC at any age
• • Known hereditary/germline risk of colorectal cancer (for example, Lynch syndrome or Hereditary Non-Polyposis CRC \[HNPCC\], or Familial Adenomatous Polyposis \[FAP\])
• • 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 at T3.