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Shield post-approval follow-up for colorectal cancer screening

Shield Post-Approval Study Protocol

Observational Guardant Health, Inc. · NCT06880055

This project will see if the Shield blood test reliably detects colorectal cancer or advanced polyps when used as a second-round screen in average-risk people aged 45–81, using colonoscopy as the comparison.

Quick facts

Study typeObservational
Enrollment3375 (estimated)
Ages45 Years to 81 Years
SexAll
SponsorGuardant Health, Inc. Industry-sponsored
Locations56 sites (Chandler, Arizona and 55 other locations)
Trial IDNCT06880055 on ClinicalTrials.gov

What this trial studies

This is a prospective, longitudinal post-approval program supplemented with real-world evidence to measure Shield’s performance when used for a second round of colorectal cancer screening. Adults aged 45 to 81 at average risk who undergo a standard-of-care Shield test are followed over time and compared to colonoscopy findings as the reference standard. The protocol collects longitudinal test results and related clinical data to characterize detection of colorectal cancer and advanced adenomas. Recruitment is occurring at outpatient gastroenterology and research sites in Arizona and California and via real-world data sources linked to those centers.

Who should consider this trial

Good fit: Adults aged 45–81 who are considered average risk for colorectal cancer and plan to undergo a standard-of-care Shield blood test are the intended participants.

Not a fit: People with prior colorectal cancer, known adenomas or inflammatory bowel disease, a family history of CRC, current symptoms prompting diagnostic colonoscopy, or other higher-risk conditions are unlikely to benefit from this average-risk screening evaluation.

Why it matters

Potential benefit: If successful, Shield could provide a less invasive blood-based option to help identify people who need diagnostic colonoscopy, potentially improving screening uptake and earlier detection.

How similar studies have performed: Other blood-based colorectal screening tests have shown modest to good performance in prior work, but longitudinal post-approval data for second-round screening with Shield specifically are limited.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Chandler, Arizona and 55 other locations

+6 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colo-rectal CancerScreeningShield
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.