RECRUITING

Shield Post-Approval Study Protocol

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Shield Post-Approval Study Protocol

Quick Facts

Study Start:2025-07-14

Study Completion:2030-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06880055

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 81 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Locations (Sites)

Christie Clinic

Champaign, Illinois, 61822

United States

Collaborators and Investigators

Sponsor: Guardant Health, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-14

Study Completion Date2030-12-01

Study Record Updates

Study Start Date2025-07-14

Study Completion Date2030-12-01

Terms related to this study

Keywords Provided by Researchers

Screening
Shield

Additional Relevant MeSH Terms

Colo-rectal Cancer