Shield Post-Approval Study Protocol
SOLAR
1 other identifier
observational
3,375
1 country
56
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2025
Longer than P75 for all trials
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2025
CompletedFirst Posted
Study publicly available on registry
March 17, 2025
CompletedStudy Start
First participant enrolled
July 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
March 19, 2026
December 1, 2025
5.1 years
March 11, 2025
March 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Performance measures of the Shield test will be assessed for the second testing interval
* Advanced Neoplasia Specificity * AA Sensitivity * CRC Sensitivity * PPV for: CRC, AA, and advanced neoplasia. * NPV for: CRC and advanced neoplasia
33-42 Months Post-Enrollment
Study Arms (1)
Enrolled Subjects
Subjects age 45 to 81 at average risk of CRC who meet inclusion, do not meet exclusion criteria, and who successfully enroll in the study.
Interventions
Shield Blood Test for colo-rectal cancer Screening
Eligibility Criteria
Subjects age 45 to 81 at average risk of CRC who meet inclusion, do not meet exclusion criteria, and who successfully enroll in the study
You may qualify if:
- Subjects aged 45-81 years at time of consent
- Intending to undergo a standard of care Shield test
- 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).
- Subject agrees to comply with study procedures and associated standard of care assessments.
You may not qualify if:
- Undergoing colonoscopy for investigation of symptoms
- Personal history of colorectal cancer (CRC), adenomas, or other related cancers
- Family history of CRC, defined as having one or more first-degree relative (parent, sibling, or child) diagnosed with CRC at any age
- Positive result on another colorectal cancer screening method within the last six months, or:
- months for fecal occult blood test (FOBT) or fecal immunochemical test (FIT)
- months for FIT-DNA test
- 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
- Positive Shield test result within the previous 3 years
- 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)
- Known diagnosis of inflammatory bowel disease
- Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs (DMARDs)
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
Southeast Valley Gastroenterology Consultants
Chandler, Arizona, 85224, United States
Southeast Valley Gastroenterology Consultants
Gilbert, Arizona, 85297, United States
Alliance Research Institute, LLC
Canoga Park, California, 91304, United States
Paragon Rx Clinical, Inc.
Garden Grove, California, 92840, United States
Amicis Research Center
Granada Hills, California, 91344, United States
Desert Oasis Healthcare Medical Group
Palm Springs, California, 92262, United States
Digestive Disease Associates
Branford, Connecticut, 06405, United States
Digestive Disease Associates
Branford, Connecticut, 06405, United States
Gastroenterology Consultants of Boca Raton, LLC
Boca Raton, Florida, 33486, United States
Physicians Group of South Florida
North Miami, Florida, 33181, United States
Digestive Disease Consultants
Bourbonnais, Illinois, 60914, United States
Digestive Disease Consultants
Bourbonnais, Illinois, 60914, United States
Christie Clinic
Champaign, Illinois, 61822, United States
Christie Clinic
Champaign, Illinois, 61822, United States
GI Solutions of Illinois
Chicago, Illinois, 60631, United States
GI Solutions of Illinois
Chicago, Illinois, 60631, United States
Digestive Health Services
Downers Grove, Illinois, 60515, United States
Digestive Health Services
Downers Grove, Illinois, 60515, United States
Gastroenterology and Internal Medicine Specialists (GAIMS)
Lake Barrington, Illinois, 60010, United States
Gastroenterology and Internal Medicine Specialists (GAIMS)
Lake Barrington, Illinois, 60010, United States
Northshore Center for Gastroenterology (NCG)
Libertyville, Illinois, 60048, United States
Southwest Gastroenterology (SWG)
Oak Lawn, Illinois, 60453, United States
Southwest Gastroenterology (SWG)
Oak Lawn, Illinois, 60453, United States
Hutchinson Clinic
Hutchinson, Kansas, 67502, United States
Northlake Gastroenterology Associates
Covington, Louisiana, 70433, United States
Northlake Gastroenterology Associates
Hammond, Louisiana, 70403, United States
Gastroenterology Associates of New Jersey, LLC
Clifton, New Jersey, 07013, United States
Gastroenterology Associates of New Jersey
Hackensack, New Jersey, 07601, United States
Gastroenterology Associates of New Jersey, LLC
Montclair, New Jersey, 07042, United States
Gastroenterology Associates of New Jersey, LLC
Ridgewood, New Jersey, 07450, United States
Gastroenterology Associates of New Jersey, LLC
Wayne, New Jersey, 07470, United States
Gastroenterology Associates of New Jersey
Wayne, New Jersey, 07470, United States
Associated Gastroenterologists of Central New York
Camillus, New York, 13031, United States
Syracuse Gastroenterological Associates, P.C.
East Syracuse, New York, 13057, United States
Associated Gastroenterologists of Central New York
Fayetteville, New York, 13066, United States
Orchard Park Family Practice
Orchard Park, New York, 14127, United States
GastroCare LI
Valley Stream, New York, 11581, United States
GastroCare LI
Valley Stream, New York, 11581, United States
Cary Gastroenterology Associates
Cary, North Carolina, 27518, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
University of North Carolina at Chapel Hill
Hillsborough, North Carolina, 27278, United States
Piedmont Healthcare, P.A.
Mocksville, North Carolina, 27028, United States
Pinehurst Medical Clinic
Pinehurst, North Carolina, 28374, United States
Sanford Cardiology Pinehurst Medical Clinic
Sanford, North Carolina, 27330, United States
Piedmont Healthcare LLC
Statesville, North Carolina, 28625, United States
US Digestive Health at Blair
Altoona, Pennsylvania, 16602, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Health Living at Pottstown Medical Specialists, Inc
Pottstown, Pennsylvania, 19464, United States
Premier Family Physicians
Austin, Texas, 78735, United States
Premier Family Physicians
Austin, Texas, 78746, United States
Integrity Advanced Therapeutics, PLLC
Houston, Texas, 77090, United States
Center for Digestive Disease
Shenandoah, Texas, 77384, United States
Horizon Clinical Research Group
Tomball, Texas, 77375, United States
Horizon Clinical Research Group
Tomball, Texas, 77375, United States
Tidewater Physician Multispecialty Group Clinical Research
Williamsburg, Virginia, 23188, United States
Biospecimen
Blood Samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2025
First Posted
March 17, 2025
Study Start
July 14, 2025
Primary Completion (Estimated)
September 1, 2030
Study Completion (Estimated)
December 1, 2030
Last Updated
March 19, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share