Actively Recruiting
Shield Post-Approval Study Protocol
Led by Guardant Health, Inc. · Updated on 2026-03-19
3375
Participants Needed
56
Research Sites
280 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Shield Post-Approval Study Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 colorectal cancer
- Average risk defined as no symptoms of colorectal cancer
- No prior diagnosis of colorectal cancer, adenomatous polyps, or inflammatory bowel disease
- No family history of colorectal cancer or known hereditary predisposition
- Subject agrees to comply with study procedures and standard of care assessments
You will not qualify if you...
- Undergoing colonoscopy due to symptoms
- Personal history of colorectal cancer, adenomas, or related cancers
- Family history of colorectal cancer (one or more first-degree relatives with CRC)
- Positive result on another colorectal cancer screening test within specified recent timeframes
- Personal history of high-risk conditions such as inflammatory bowel disease or hereditary cancer syndromes
- Positive Shield test result within previous 3 years
- History of any malignancy except treated skin squamous cell cancer over 12 months ago
- Known diagnosis of inflammatory bowel disease
- Currently taking anti-neoplastic or disease-modifying anti-rheumatic drugs
- Major physical trauma within 30 days before consent
- Any medical condition judged by Investigator to preclude enrollment
- Participation in clinical research involving experimental medications within 30 days before consent or during colonoscopy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 56 locations
1
Southeast Valley Gastroenterology Consultants
Chandler, Arizona, United States, 85224
Actively Recruiting
2
Southeast Valley Gastroenterology Consultants
Gilbert, Arizona, United States, 85297
Actively Recruiting
3
Alliance Research Institute, LLC
Canoga Park, California, United States, 91304
Actively Recruiting
4
Paragon Rx Clinical, Inc.
Garden Grove, California, United States, 92840
Withdrawn
5
Amicis Research Center
Granada Hills, California, United States, 91344
Actively Recruiting
6
Desert Oasis Healthcare Medical Group
Palm Springs, California, United States, 92262
Actively Recruiting
7
Digestive Disease Associates
Branford, Connecticut, United States, 06405
Actively Recruiting
8
Digestive Disease Associates
Branford, Connecticut, United States, 06405
Actively Recruiting
9
Gastroenterology Consultants of Boca Raton, LLC
Boca Raton, Florida, United States, 33486
Actively Recruiting
10
Physicians Group of South Florida
North Miami, Florida, United States, 33181
Actively Recruiting
11
Digestive Disease Consultants
Bourbonnais, Illinois, United States, 60914
Actively Recruiting
12
Digestive Disease Consultants
Bourbonnais, Illinois, United States, 60914
Actively Recruiting
13
Christie Clinic
Champaign, Illinois, United States, 61822
Actively Recruiting
14
Christie Clinic
Champaign, Illinois, United States, 61822
Active, Not Recruiting
15
GI Solutions of Illinois
Chicago, Illinois, United States, 60631
Actively Recruiting
16
GI Solutions of Illinois
Chicago, Illinois, United States, 60631
Actively Recruiting
17
Digestive Health Services
Downers Grove, Illinois, United States, 60515
Actively Recruiting
18
Digestive Health Services
Downers Grove, Illinois, United States, 60515
Actively Recruiting
19
Gastroenterology and Internal Medicine Specialists (GAIMS)
Lake Barrington, Illinois, United States, 60010
Actively Recruiting
20
Gastroenterology and Internal Medicine Specialists (GAIMS)
Lake Barrington, Illinois, United States, 60010
Actively Recruiting
21
Northshore Center for Gastroenterology (NCG)
Libertyville, Illinois, United States, 60048
Actively Recruiting
22
Southwest Gastroenterology (SWG)
Oak Lawn, Illinois, United States, 60453
Actively Recruiting
23
Southwest Gastroenterology (SWG)
Oak Lawn, Illinois, United States, 60453
Actively Recruiting
24
Hutchinson Clinic
Hutchinson, Kansas, United States, 67502
Active, Not Recruiting
25
Northlake Gastroenterology Associates
Covington, Louisiana, United States, 70433
Actively Recruiting
26
Northlake Gastroenterology Associates
Hammond, Louisiana, United States, 70403
Actively Recruiting
27
Gastroenterology Associates of New Jersey, LLC
Clifton, New Jersey, United States, 07013
Actively Recruiting
28
Gastroenterology Associates of New Jersey
Hackensack, New Jersey, United States, 07601
Active, Not Recruiting
29
Gastroenterology Associates of New Jersey, LLC
Montclair, New Jersey, United States, 07042
Actively Recruiting
30
Gastroenterology Associates of New Jersey, LLC
Ridgewood, New Jersey, United States, 07450
Actively Recruiting
31
Gastroenterology Associates of New Jersey, LLC
Wayne, New Jersey, United States, 07470
Actively Recruiting
32
Gastroenterology Associates of New Jersey
Wayne, New Jersey, United States, 07470
Active, Not Recruiting
33
Associated Gastroenterologists of Central New York
Camillus, New York, United States, 13031
Actively Recruiting
34
Syracuse Gastroenterological Associates, P.C.
East Syracuse, New York, United States, 13057
Actively Recruiting
35
Associated Gastroenterologists of Central New York
Fayetteville, New York, United States, 13066
Actively Recruiting
36
Orchard Park Family Practice
Orchard Park, New York, United States, 14127
Actively Recruiting
37
GastroCare LI
Valley Stream, New York, United States, 11581
Actively Recruiting
38
GastroCare LI
Valley Stream, New York, United States, 11581
Actively Recruiting
39
Cary Gastroenterology Associates
Cary, North Carolina, United States, 27518
Actively Recruiting
40
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
41
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
42
University of North Carolina at Chapel Hill
Hillsborough, North Carolina, United States, 27278
Actively Recruiting
43
Piedmont Healthcare, P.A.
Mocksville, North Carolina, United States, 27028
Active, Not Recruiting
44
Pinehurst Medical Clinic
Pinehurst, North Carolina, United States, 28374
Withdrawn
45
Sanford Cardiology Pinehurst Medical Clinic
Sanford, North Carolina, United States, 27330
Withdrawn
46
Piedmont Healthcare LLC
Statesville, North Carolina, United States, 28625
Active, Not Recruiting
47
US Digestive Health at Blair
Altoona, Pennsylvania, United States, 16602
Actively Recruiting
48
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
49
Health Living at Pottstown Medical Specialists, Inc
Pottstown, Pennsylvania, United States, 19464
Actively Recruiting
50
Premier Family Physicians
Austin, Texas, United States, 78735
Active, Not Recruiting
51
Premier Family Physicians
Austin, Texas, United States, 78746
Active, Not Recruiting
52
Integrity Advanced Therapeutics, PLLC
Houston, Texas, United States, 77090
Actively Recruiting
53
Center for Digestive Disease
Shenandoah, Texas, United States, 77384
Actively Recruiting
54
Horizon Clinical Research Group
Tomball, Texas, United States, 77375
Actively Recruiting
55
Horizon Clinical Research Group
Tomball, Texas, United States, 77375
Actively Recruiting
56
Tidewater Physician Multispecialty Group Clinical Research
Williamsburg, Virginia, United States, 23188
Actively Recruiting
Research Team
H
Hannah Oakley
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here