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NCT06880055ClinicalTrials.gov

Shield Post-Approval Study Protocol

RecruitingTaking participants now, according to the registry record.
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In brief

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…

Observational3,375 participants sought69 sites1 country

Categories

Oncology60%Gastroenterology & hepatology40%

Registered in 1 registry

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2025-03-17; recorded start 2025-07-14
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Whether participants are randomly assigned is not stated in the registry recordNo allocation method is recorded
  • A comparison group is not stated in the registry recordThe record describes a single study arm
  • Whether the study is blinded is not stated in the registry recordNo masking information is recorded
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 5 other studies in this databaseCounted from the lead sponsor named in the record (Guardant Health, Inc.)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation0/20

    Allocation not stated in the record

  • Blinding0/20

    Masking not stated in the record

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 56 sites

  • Data monitoring committee0/7

    No data monitoring committee stated

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study: 3,375 participants (target), run at 69 sites.

How this score is built
  • Enrolment35/40

    3,375 participants (target)

  • Site count20/25

    56 sites

  • Country count0/15

    Single country

  • Planned duration10/10

    Planned over about 66 months

  • Sponsor scale2/10

    Guardant Health, Inc. has led 6 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

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.

Colorectal cancer (CRC) is the fourth most diagnosed cancer and second leading cause of cancer-related death in the US, with an estimated 53,010 deaths attributable to CRC in 2024. The risk of CRC increases with age, with the majority of cases and deaths occurring in individuals aged 65 years or older. While the incidence of CRC in Americans 65 years of age or older has decreased over the last decade, the incidence of CRC in younger Americans aged 55 years or younger has been increasing since the mid-1990s. CRC disproportionately affects minority populations, with American Indian/Alaska Native and Black/African American populations having the highest incidence and mortality rates1; this is further exacerbated by systemic barriers to current CRC screening options. CRC primarily arises from a precursor lesion, the adenomatous polyp (i.e., adenoma), that grows from the epithelial cells of the colorectal mucosa. Adenomas that grow larger than 10 mm or have elements indicating a risk of malignant transformation (e.g., high-grade dysplasia or villous features) are defined as advanced adenomas (AAs). The vast number of adenomas, even those with features classifying them as AAs, do not progress into a colorectal malignancy. Colonoscopy cannot always distinguish adenomas or advanced adenomas from other polyp histology; thus, polypectomy is routinely performed for lesions identified on endoscopy. The transition rate from adenoma onset to CRC development is estimated to be 12.5 to 25 years. This slow transition from adenoma onset to CRC onset allows for multiple CRC screening opportunities over a lifetime, providing the ability to intervene along the disease development course and the potential to detect and remove adenomas, prevent colorectal cancer, and reduce CRC incidence and subsequently, disease mortality. Once CRC has developed, tumor staging is consistent with other solid tumors and defined based on how far the cancer has spread within the body. In Stage 0 (carcinoma in situ), the cancer cells are only in the colorectal mucosa. In Stage I, the cancer has spread to the muscular layer of the colorectum but not to nearby tissue or lymph nodes. In Stage II, the cancer has grown through the wall of the colorectum and potentially to nearby tissues but has not spread to nearby lymph nodes. In Stage III, the cancer has spread to nearby lymph nodes but not to distant parts of the body. In Stage IV, the cancer has spread to one or more distant parts of the body. The estimated time frame from CRC onset to a symptomatic diagnosis of CRC is estimated to be 4-5 years, in the absence of early detection through asymptomatic cancer screening. Tumor size and location can influence the rate of transition through the stages of CRC. The 5-year survival rate for localized disease (Stage I-II) is 91%, and is 72% for regional disease (Stage III), while the 5-year survival for metastatic disease (Stage IV) is only 14%. These statistics highlight the ability to reduce CRC-related mortality by detection of early-stage (Stage I-III) disease where therapeutic intervention has the potential to result in a cure.

Conditions

  • Colo-rectal Cancer

Eligibility

SexAll
Ages45 Years – 81 Years
Healthy volunteersYes
Sampling methodPROBABILITY_SAMPLE

Study population

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

Eligibility as written in the registry

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

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study typeObservational
PhaseNot stated in the registry record
AllocationNot stated in the registry record
Intervention modelNot stated in the registry record
Primary purposeNot stated in the registry record
MaskingNot stated in the registry record
Enrolment3,375 participants sought

Sponsor and collaborators

  • Guardant Health, Inc. Sponsor

Arms and interventions

  • 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

  • Diagnostic test Shield Blood Test for colo-rectal cancer Screening

    Shield Blood Test for colo-rectal cancer Screening

Outcome measures

  1. Primary outcome

    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

    Time frame 33-42 Months Post-Enrollment

Dates

Start dateJuly 14, 2025 (actual)
Primary completionSeptember 1, 2030 (estimated)
CompletionDecember 1, 2030 (estimated)
First postedMarch 17, 2025 (actual)
Last updatedAugust 7, 2026
Results postedNot stated in the registry record
Status last verifiedAugust 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

58 sites are recruiting

United States

FacilityCityState or regionStatus
US Digestive Health at BlairAltoonaPennsylvaniaRecruiting
Elite Primary Physicians, Inc.AnaheimCaliforniaRecruiting
Premier Family PhysiciansAustinTexasActive, not recruiting
Premier Family PhysiciansAustinTexasActive, not recruiting
Embassy Research NetworkBloomfield TownshipMichiganRecruiting
Gastroenterology Consultants of Boca Raton, LLCBoca RatonFloridaRecruiting
Digestive Disease ConsultantsBourbonnaisIllinoisRecruiting
Digestive Disease ConsultantsBourbonnaisIllinoisRecruiting
Digestive Disease AssociatesBranfordConnecticutRecruiting
Digestive Disease AssociatesBranfordConnecticutRecruiting
Associated Gastroenterologists of Central New YorkCamillusNew YorkRecruiting
Alliance Research Institute, LLCCanoga ParkCaliforniaRecruiting
Cary Gastroenterology AssociatesCaryNorth CarolinaRecruiting
Christie ClinicChampaignIllinoisActive, not recruiting
Christie ClinicChampaignIllinoisRecruiting
Southeast Valley Gastroenterology ConsultantsChandlerArizonaRecruiting
University of North Carolina at Chapel HillChapel HillNorth CarolinaRecruiting
University of North Carolina at Chapel HillChapel HillNorth CarolinaRecruiting
GI Solutions of IllinoisChicagoIllinoisRecruiting
GI Solutions of IllinoisChicagoIllinoisRecruiting
Gastroenterology Associates of New Jersey, LLCCliftonNew JerseyRecruiting
Northlake Gastroenterology AssociatesCovingtonLouisianaRecruiting
Manuel Espinel MD PADelray BeachFloridaRecruiting
Innova Pharma Research, LLCDoralFloridaRecruiting
Digestive Health ServicesDowners GroveIllinoisRecruiting
Digestive Health ServicesDowners GroveIllinoisRecruiting
Syracuse Gastroenterological Associates, P.C.East SyracuseNew YorkRecruiting
Associated Gastroenterologists of Central New YorkFayettevilleNew YorkRecruiting
Paragon Rx Clinical, Inc.Garden GroveCaliforniaWithdrawn
Southeast Valley Gastroenterology ConsultantsGilbertArizonaRecruiting
Amicis Research CenterGranada HillsCaliforniaRecruiting
Gastroenterology Associates of New JerseyHackensackNew JerseyActive, not recruiting
Northlake Gastroenterology AssociatesHammondLouisianaRecruiting
University of North Carolina at Chapel HillHillsboroughNorth CarolinaRecruiting
Integrity Advanced Therapeutics, PLLCHoustonTexasRecruiting
Hutchinson ClinicHutchinsonKansasActive, not recruiting
Gastroenterology and Internal Medicine Specialists (GAIMS)Lake BarringtonIllinoisRecruiting
Gastroenterology and Internal Medicine Specialists (GAIMS)Lake BarringtonIllinoisRecruiting
Northshore Center for Gastroenterology (NCG)LibertyvilleIllinoisRecruiting
Research Associates of South Florida, LLCMiamiFloridaRecruiting
Marisela Gonzalez, MDMiamiFloridaRecruiting
Florida South Research Phase I-IV, Inc.MiamiFloridaRecruiting
Piedmont Healthcare, P.A.MocksvilleNorth CarolinaActive, not recruiting
Gastroenterology Associates of New Jersey, LLCMontclairNew JerseyRecruiting
NYU LangoneNew YorkNew YorkRecruiting
Physicians Group of South FloridaNorth MiamiFloridaRecruiting
Southwest Gastroenterology (SWG)Oak LawnIllinoisRecruiting
Southwest Gastroenterology (SWG)Oak LawnIllinoisRecruiting
Orchard Park Family PracticeOrchard ParkNew YorkRecruiting
Desert Oasis Healthcare Medical GroupPalm SpringsCaliforniaRecruiting

19 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

  1. August 7, 2026

    Site added

    13 sites added (69 total)

    5669

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06880055