Actively Recruiting
Shield Post-Approval Study Protocol for Colorectal Cancer Screening Using the Shield Blood Test
Led by Guardant Health, Inc. · Updated on 2026-03-19
3375
Participants Needed
56
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the performance of the Shield blood test for colorectal cancer (CRC) screening in individuals aged 45 to 81 who are at average risk for CRC. The study focuses on the second round of testing and compares the Shield test results to colonoscopy findings. This observational study aims to gather real-world evidence on how well the Shield test detects CRC in this population, addressing the importance of early detection to reduce CRC incidence and mortality. Participants will undergo the Shield blood test at the second testing interval, which occurs between 33 and 42 months after enrollment. The study involves adults who are considered average risk for CRC, meaning they lack symptoms or increased risk factors such as a personal or family history of CRC or related conditions. The Shield test is the primary diagnostic tool being assessed, and colonoscopy is used as the reference method to evaluate its performance. During the study, participants will follow standard care procedures and comply with study assessments. Researchers will measure how well the Shield test performs at detecting CRC at the second testing interval. The study includes monitoring participants over time with standard clinical assessments and the collection of data related to CRC screening outcomes. Participation involves scheduled testing and evaluations, with safety and adherence tracked throughout the study period, which extends until December 2030.
CONDITIONS
Brief Title
Shield Post-Approval Study Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects aged 45 to 81 years at the time of consent
- Planning to undergo a standard of care Shield blood test
- Considered average risk for colorectal cancer by a healthcare provider, meaning no symptoms or increased risk factors like prior CRC, adenomatous polyps, inflammatory bowel disease, or family history
- Willing to comply with study procedures and standard 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 in a first-degree relative
- Positive result on another colorectal cancer screening test within specified recent timeframes
- Personal history of high-risk conditions such as inflammatory bowel disease, familial adenomatous polyposis, or hereditary cancer syndromes
- Positive Shield test result within the last 3 years
- History of any malignancy except certain skin cancers treated over 12 months ago
- Taking anti-neoplastic or disease-modifying anti-rheumatic drugs
- Major physical trauma within 30 days prior to consent
- Medical conditions deemed unsuitable by the investigator
- Participation in another clinical trial with experimental medication within 30 days prior to consent or ongoing through colonoscopy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single test at enrollment
Participants undergo the Shield Blood Test for colorectal cancer screening as part of the observational study.
1 baseline visit (in-person)
Duration - Up to 42 months post-enrollment
Participants are followed over time to assess the performance of the Shield Blood Test and to monitor for colorectal cancer development.
Periodic follow-up assessments up to 42 months
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
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
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