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NCT06880055ClinicalTrials.gov

Shield Post-Approval Study Protocol

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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…

Observationnelle3 375 participants recherchés69 sites1 pays

Catégories

Oncologie60%Gastro-entérologie et hépatologie40%

Enregistré dans 1 registre

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Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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.

Affections

  • Colo-rectal Cancer

Éligibilité

SexeTous
Âges45 Years – 81 Years
Volontaires sainsOui
Méthode d'échantillonnagePROBABILITY_SAMPLE

Population de l'étude

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

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeObservationnelle
PhaseNon précisé dans la fiche du registre
RépartitionNon précisé dans la fiche du registre
Modèle d'interventionNon précisé dans la fiche du registre
Objectif principalNon précisé dans la fiche du registre
InsuNon précisé dans la fiche du registre
Recrutement3 375 participants recherchés

Promoteur et collaborateurs

  • Guardant Health, Inc. Promoteur

Groupes et 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

  • Test diagnostique Shield Blood Test for colo-rectal cancer Screening

    Shield Blood Test for colo-rectal cancer Screening

Critères de jugement

  1. Critère de jugement principal

    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

    Délai 33-42 Months Post-Enrollment

Dates

Date de début14 juillet 2025 (réelle)
Achèvement principal1 septembre 2030 (estimée)
Achèvement1 décembre 2030 (estimée)
Première publication17 mars 2025 (réelle)
Dernière mise à jour7 août 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisaoût 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

58 sites sont en recrutement

United States

ÉtablissementVilleÉtat ou régionStatut
US Digestive Health at BlairAltoonaPennsylvaniaEn recrutement
Elite Primary Physicians, Inc.AnaheimCaliforniaEn recrutement
Premier Family PhysiciansAustinTexasActif, sans recrutement
Premier Family PhysiciansAustinTexasActif, sans recrutement
Embassy Research NetworkBloomfield TownshipMichiganEn recrutement
Gastroenterology Consultants of Boca Raton, LLCBoca RatonFloridaEn recrutement
Digestive Disease ConsultantsBourbonnaisIllinoisEn recrutement
Digestive Disease ConsultantsBourbonnaisIllinoisEn recrutement
Digestive Disease AssociatesBranfordConnecticutEn recrutement
Digestive Disease AssociatesBranfordConnecticutEn recrutement
Associated Gastroenterologists of Central New YorkCamillusNew YorkEn recrutement
Alliance Research Institute, LLCCanoga ParkCaliforniaEn recrutement
Cary Gastroenterology AssociatesCaryNorth CarolinaEn recrutement
Christie ClinicChampaignIllinoisActif, sans recrutement
Christie ClinicChampaignIllinoisEn recrutement
Southeast Valley Gastroenterology ConsultantsChandlerArizonaEn recrutement
University of North Carolina at Chapel HillChapel HillNorth CarolinaEn recrutement
University of North Carolina at Chapel HillChapel HillNorth CarolinaEn recrutement
GI Solutions of IllinoisChicagoIllinoisEn recrutement
GI Solutions of IllinoisChicagoIllinoisEn recrutement
Gastroenterology Associates of New Jersey, LLCCliftonNew JerseyEn recrutement
Northlake Gastroenterology AssociatesCovingtonLouisianaEn recrutement
Manuel Espinel MD PADelray BeachFloridaEn recrutement
Innova Pharma Research, LLCDoralFloridaEn recrutement
Digestive Health ServicesDowners GroveIllinoisEn recrutement
Digestive Health ServicesDowners GroveIllinoisEn recrutement
Syracuse Gastroenterological Associates, P.C.East SyracuseNew YorkEn recrutement
Associated Gastroenterologists of Central New YorkFayettevilleNew YorkEn recrutement
Paragon Rx Clinical, Inc.Garden GroveCaliforniaRetiré
Southeast Valley Gastroenterology ConsultantsGilbertArizonaEn recrutement
Amicis Research CenterGranada HillsCaliforniaEn recrutement
Gastroenterology Associates of New JerseyHackensackNew JerseyActif, sans recrutement
Northlake Gastroenterology AssociatesHammondLouisianaEn recrutement
University of North Carolina at Chapel HillHillsboroughNorth CarolinaEn recrutement
Integrity Advanced Therapeutics, PLLCHoustonTexasEn recrutement
Hutchinson ClinicHutchinsonKansasActif, sans recrutement
Gastroenterology and Internal Medicine Specialists (GAIMS)Lake BarringtonIllinoisEn recrutement
Gastroenterology and Internal Medicine Specialists (GAIMS)Lake BarringtonIllinoisEn recrutement
Northshore Center for Gastroenterology (NCG)LibertyvilleIllinoisEn recrutement
Research Associates of South Florida, LLCMiamiFloridaEn recrutement
Marisela Gonzalez, MDMiamiFloridaEn recrutement
Florida South Research Phase I-IV, Inc.MiamiFloridaEn recrutement
Piedmont Healthcare, P.A.MocksvilleNorth CarolinaActif, sans recrutement
Gastroenterology Associates of New Jersey, LLCMontclairNew JerseyEn recrutement
NYU LangoneNew YorkNew YorkEn recrutement
Physicians Group of South FloridaNorth MiamiFloridaEn recrutement
Southwest Gastroenterology (SWG)Oak LawnIllinoisEn recrutement
Southwest Gastroenterology (SWG)Oak LawnIllinoisEn recrutement
Orchard Park Family PracticeOrchard ParkNew YorkEn recrutement
Desert Oasis Healthcare Medical GroupPalm SpringsCaliforniaEn recrutement

19 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

  1. 7 août 2026

    Site ajouté

    13 sites added (69 total)

    5669

Registre: ClinicalTrials.gov · NCT########

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