Shield Test for Average-Risk Colorectal Cancer

Shield Post-Approval Study Protocol

Recruiting Observational Study
Colo-rectal Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part. No Study Drug Researchers observe your health over time — no experimental treatment is given.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
45 – 81
Sex
Any
Study type
Observational
Participants needed
3,375 (estimated)
Sponsor
Guardant Health, Inc. · Industry
Who this trial is looking for

This trial is looking for people aged 45 to 81 who are at average risk for colorectal cancer and are planning to take a Shield test. Participants will be followed over time to evaluate the test's performance.

Are You a Good Fit for This Trial?
Rules you out Colorectal cancerInflammatory bowel disease

You may be able to join if

  • I am between 45 and 81 years old.
  • I plan to take a standard Shield test.
  • My doctor says I am at average risk for colorectal cancer.
  • I agree to follow the study procedures.

You may not be able to join if

  • I am undergoing colonoscopy to investigate symptoms.
  • I have a personal history of colorectal cancer or adenomas.
  • I have a family history of colorectal cancer.
  • I had a positive result on another colorectal cancer screening in the last 6 months.
  • I have inflammatory bowel disease or other high-risk conditions.
  • I had a positive Shield test result in the last 3 years.
  • I have a history of any malignancy besides skin squamous cell cancer removed over a year ago.
  • I am currently taking anti-neoplastic or disease-modifying drugs.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
About This Trial

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.

Trial Locations
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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 n…
Contacts

Hannah Oakley

415-307-2774

solar@guardanthealth.com

CONTACT