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NCT06880055ClinicalTrials.gov

Shield Post-Approval Study Protocol

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En resumen

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…

Observacional3375 participantes buscados69 centros1 país

Categorías

Oncología60%Gastroenterología y hepatología40%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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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.

Resumen

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.

Afecciones

  • Colo-rectal Cancer

Elegibilidad

SexoTodos
Edades45 Years – 81 Years
Voluntarios sanosSí
Método de muestreoPROBABILITY_SAMPLE

Población del estudio

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

Elegibilidad tal como figura en el registro

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

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioObservacional
FaseNo indicado en el registro
AsignaciónNo indicado en el registro
Modelo de intervenciónNo indicado en el registro
Propósito principalNo indicado en el registro
EnmascaramientoNo indicado en el registro
Inscripción3375 participantes buscados

Patrocinador y colaboradores

  • Guardant Health, Inc. Patrocinador

Grupos e intervenciones

  • 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.

Intervenciones

  • Prueba diagnóstica Shield Blood Test for colo-rectal cancer Screening

    Shield Blood Test for colo-rectal cancer Screening

Variables de resultado

  1. Variable de resultado 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

    Plazo 33-42 Months Post-Enrollment

Fechas

Fecha de inicio14 de julio de 2025 (real)
Finalización principal1 de septiembre de 2030 (estimada)
Finalización1 de diciembre de 2030 (estimada)
Primera publicación17 de marzo de 2025 (real)
Última actualización7 de agosto de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezagosto de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

58 centros están en reclutamiento

United States

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

En el registro figuran 19 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 7 de agosto de 2026

    Centro añadido

    13 sites added (69 total)

    5669

Registro: ClinicalTrials.gov · NCT########

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