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NCT06880055ClinicalTrials.gov

Shield Post-Approval Study Protocol

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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…

Osservazionale3375 partecipanti ricercati69 centri1 paese

Categorie

Oncologia60%Gastroenterologia ed epatologia40%

Registrato in 1 registro

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Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

Sintesi

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.

Patologie

  • Colo-rectal Cancer

Idoneità

SessoTutti
Età45 Years – 81 Years
Volontari saniSì
Metodo di campionamentoPROBABILITY_SAMPLE

Popolazione dello studio

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

Idoneità come riportata nel 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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioOsservazionale
FaseNon indicato nella scheda del registro
AssegnazioneNon indicato nella scheda del registro
Modello di interventoNon indicato nella scheda del registro
Finalità principaleNon indicato nella scheda del registro
MascheramentoNon indicato nella scheda del registro
Arruolamento3375 partecipanti ricercati

Sponsor e collaboratori

  • Guardant Health, Inc. Sponsor

Bracci e interventi

  • 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.

Interventi

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

    Shield Blood Test for colo-rectal cancer Screening

Esiti misurati

  1. Esito primario

    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

    Orizzonte temporale 33-42 Months Post-Enrollment

Date

Data di inizio14 luglio 2025 (effettiva)
Conclusione primaria1 settembre 2030 (stimata)
Conclusione1 dicembre 2030 (stimata)
Prima pubblicazione17 marzo 2025 (effettiva)
Ultimo aggiornamento7 agosto 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltaagosto 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

58 centri stanno reclutando

United States

StrutturaCittàStato o regioneStato
US Digestive Health at BlairAltoonaPennsylvaniaIn reclutamento
Elite Primary Physicians, Inc.AnaheimCaliforniaIn reclutamento
Premier Family PhysiciansAustinTexasAttivo, non in reclutamento
Premier Family PhysiciansAustinTexasAttivo, non in reclutamento
Embassy Research NetworkBloomfield TownshipMichiganIn reclutamento
Gastroenterology Consultants of Boca Raton, LLCBoca RatonFloridaIn reclutamento
Digestive Disease ConsultantsBourbonnaisIllinoisIn reclutamento
Digestive Disease ConsultantsBourbonnaisIllinoisIn reclutamento
Digestive Disease AssociatesBranfordConnecticutIn reclutamento
Digestive Disease AssociatesBranfordConnecticutIn reclutamento
Associated Gastroenterologists of Central New YorkCamillusNew YorkIn reclutamento
Alliance Research Institute, LLCCanoga ParkCaliforniaIn reclutamento
Cary Gastroenterology AssociatesCaryNorth CarolinaIn reclutamento
Christie ClinicChampaignIllinoisAttivo, non in reclutamento
Christie ClinicChampaignIllinoisIn reclutamento
Southeast Valley Gastroenterology ConsultantsChandlerArizonaIn reclutamento
University of North Carolina at Chapel HillChapel HillNorth CarolinaIn reclutamento
University of North Carolina at Chapel HillChapel HillNorth CarolinaIn reclutamento
GI Solutions of IllinoisChicagoIllinoisIn reclutamento
GI Solutions of IllinoisChicagoIllinoisIn reclutamento
Gastroenterology Associates of New Jersey, LLCCliftonNew JerseyIn reclutamento
Northlake Gastroenterology AssociatesCovingtonLouisianaIn reclutamento
Manuel Espinel MD PADelray BeachFloridaIn reclutamento
Innova Pharma Research, LLCDoralFloridaIn reclutamento
Digestive Health ServicesDowners GroveIllinoisIn reclutamento
Digestive Health ServicesDowners GroveIllinoisIn reclutamento
Syracuse Gastroenterological Associates, P.C.East SyracuseNew YorkIn reclutamento
Associated Gastroenterologists of Central New YorkFayettevilleNew YorkIn reclutamento
Paragon Rx Clinical, Inc.Garden GroveCaliforniaRitirato
Southeast Valley Gastroenterology ConsultantsGilbertArizonaIn reclutamento
Amicis Research CenterGranada HillsCaliforniaIn reclutamento
Gastroenterology Associates of New JerseyHackensackNew JerseyAttivo, non in reclutamento
Northlake Gastroenterology AssociatesHammondLouisianaIn reclutamento
University of North Carolina at Chapel HillHillsboroughNorth CarolinaIn reclutamento
Integrity Advanced Therapeutics, PLLCHoustonTexasIn reclutamento
Hutchinson ClinicHutchinsonKansasAttivo, non in reclutamento
Gastroenterology and Internal Medicine Specialists (GAIMS)Lake BarringtonIllinoisIn reclutamento
Gastroenterology and Internal Medicine Specialists (GAIMS)Lake BarringtonIllinoisIn reclutamento
Northshore Center for Gastroenterology (NCG)LibertyvilleIllinoisIn reclutamento
Research Associates of South Florida, LLCMiamiFloridaIn reclutamento
Marisela Gonzalez, MDMiamiFloridaIn reclutamento
Florida South Research Phase I-IV, Inc.MiamiFloridaIn reclutamento
Piedmont Healthcare, P.A.MocksvilleNorth CarolinaAttivo, non in reclutamento
Gastroenterology Associates of New Jersey, LLCMontclairNew JerseyIn reclutamento
NYU LangoneNew YorkNew YorkIn reclutamento
Physicians Group of South FloridaNorth MiamiFloridaIn reclutamento
Southwest Gastroenterology (SWG)Oak LawnIllinoisIn reclutamento
Southwest Gastroenterology (SWG)Oak LawnIllinoisIn reclutamento
Orchard Park Family PracticeOrchard ParkNew YorkIn reclutamento
Desert Oasis Healthcare Medical GroupPalm SpringsCaliforniaIn reclutamento

Nella scheda del registro sono indicati altri 19 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

  1. 7 agosto 2026

    Centro aggiunto

    13 sites added (69 total)

    5669

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

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