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Shield Blood Test for Colorectal Cancer Screening

This study is evaluating the Shield Blood Test for colorectal cancer screening. It's an observational study, meaning researchers will follow participants over time to see how the test performs. You may be able to join if you are between 45 and 81 years old, are considered to be at 'average risk' for colorectal cancer by your doctor, and plan to have a standard Shield test. The study will look at how well the Shield test works during a second round of testing, specifically between 33 and 42 months after you enroll. The study aims to enroll 3375 participants.

Study design
This is an observational study that plans to enroll 3375 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to assess the Shield test's performance between 33 and 42 months after enrollment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06880055

Shield Post-Approval Study Protocol

Recruiting
Not specifiedAges 45–81Observational
Guardant Health, Inc.
~3,375 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:Shield Blood Test for colo-rectal cancer Screening

At a glance

Recruiting sites
58 of 69 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Performance measures of the Shield test will be assessed for the second testing interval
Measured over 33-42 Months Post-Enrollment

Conditions

Colo-rectal Cancer

Explore related trials

Colorectal Carcinoma

Where it's being run

69 sites across 15 states
Illinois13
California8
Florida8
North Carolina8
New York7
New Jersey6
Texas6
Pennsylvania3

Who to contact

Hannah Oakley
[email protected]
415-307-2774
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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

What this trial measures

  • Performance measures of the Shield test will be assessed for the second testing interval33-42 Months Post-Enrollment

    * Advanced Neoplasia Specificity * AA Sensitivity * CRC Sensitivity * PPV for: CRC, AA, and advanced neoplasia. * NPV for: CRC and advanced neoplasia