Shield post-approval follow-up for colorectal cancer screening

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Southeast Valley Gastroenterology Consultants
  Chandler, Arizona, United States Recruiting
• Southeast Valley Gastroenterology Consultants
  Gilbert, Arizona, United States Recruiting
• Elite Primary Physicians, Inc.
  Anaheim, California, United States Recruiting
• Alliance Research Institute, LLC
  Canoga Park, California, United States Recruiting
• Amicis Research Center
  Granada Hills, California, United States Recruiting
• Desert Oasis Healthcare Medical Group
  Palm Springs, California, United States Recruiting

+19 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Hannah Oakley
• Email: solar@guardanthealth.com
• Phone: 415-307-2774

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Prehabilitation before high-risk cancer surgery

  This trial tests a multidisciplinary prehabilitation program to see if it helps adults with cancer recover better after major abdominal surgery.

  Recruiting Fox Chase Cancer Center · Philadelphia, Pennsylvania · NCT07638410

• Personal cancer risk testing using genetic, blood, and tumor monitoring

  This project will test whether combining genetic testing, blood-based analyses, and tumor tissue checks can identify personal cancer risk and detect early recurrence in adults with breast, ovarian, colorectal, melanoma, or certain non-small cell lung cancers.

  Recruiting Fondazione del Piemonte per l'Oncologia · Candiolo, Turin · NCT07469709

• Liquid biopsy and machine learning to detect early colorectal cancer, advanced adenomas, Lynch-related cancers, and residual disease

  This project will test a blood-based liquid biopsy that uses microRNA signals and machine learning to detect colorectal cancer, advanced adenomas, Lynch-associated cancers, and molecular residual disease in people who have a colonoscopy.

  Recruiting San Raffaele University · Milan, Lombardy and 3 other locations · NCT07450612

• Colorectal Cancer Screening Outreach for Better Adherence

  This trial tests a bundled messaging approach to help adults at risk complete colorectal cancer screening.

  Recruiting Yale University · New Haven, Connecticut · NCT07345676

• Blood-based delta-HLD methylation test for detecting colorectal cancer

  This will try a blood-based delta-HLD methylation test to see if it can detect colorectal cancer in people scheduled for colonoscopy or colorectal surgery.

  Recruiting Epiliquid Holding, Inc · Mendoza · NCT07148297

• MBRC-201 dose-finding and safety in advanced metastatic solid tumors

  We will test different doses of an antibody-drug conjugate called MBRC-201 in adults whose advanced metastatic cancers (including prostate, breast, colorectal, lung, and pancreatic cancer) have not responded to standard treatments.

  Recruiting at 7 sites Phase 1/2 MBrace Therapeutics · San Francisco, California and 6 other locations · NCT07145255

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.