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Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing

12. maj 2015 opdateret af: Exact Sciences Corporation
The objective of this study is to confirm the sensitivity and specificity of a stool DNA test for detection of colorectal cancer and pre-cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Patients who have recently undergone a colonoscopy that resulted with normal findings will be asked to submit a stool sample (s) (at least 30 days AFTER colonoscopy).

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

674

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85710
        • Desert Sun Clinical Research
    • California
      • Pomona, California, Forenede Stater, 91767
        • REMEK Research
      • San Diego, California, Forenede Stater, 92101
        • Sharp Rees-Stealy
      • Santa Monica, California, Forenede Stater, 90404
        • Southern California Medical Gastroenterology Group, Inc
    • Florida
      • Miami, Florida, Forenede Stater, 33173
        • Miami Research Associates
    • Georgia
      • Marietta, Georgia, Forenede Stater, 30067
        • Atlanta Gastroenterology Associates
    • Illinois
      • Rockford, Illinois, Forenede Stater, 61107
        • Rockford Gastroenterology Associates, Ltd.
    • Louisiana
      • Metairie, Louisiana, Forenede Stater, 70006
        • New Orleans Research Institue
    • Maryland
      • Columbia, Maryland, Forenede Stater, 21045
        • Columbia Medical Practice
    • Pennsylvania
      • Perkasie, Pennsylvania, Forenede Stater, 18944
        • Main Line Gastroenterology
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • Professional Quality Research, Inc.
    • Utah
      • Ogden, Utah, Forenede Stater, 84405
        • Advanced Research Institute
      • Sandy, Utah, Forenede Stater, 84094
        • Advanced Research Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år til 84 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients are at average risk of developing colorectal cancer at the time of their colonoscopy and the colonoscopy resulted in normal findings.

Beskrivelse

Inclusion Criteria:

  • Subject is male or female, 50-84 years of age, inclusive.
  • Subject is at average risk for development of CRC and has undergone a screening colonoscopy with a normal result at least 30 days and no more than 120 days before providing a stool sample for the study. For the purposes of this study, a "normal" colonoscopy result is defined as no polyps of any size detected or removed (including benign, hyperplastic polyps).
  • Subject is able to understand the study procedures, and is able to provide signed consent to participate in the study and authorizes release of relevant protected health information through signing a HIPAA consent.
  • Subject is able and willing to provide stool samples at least 30 days and no more than 120 days after undergoing a colonoscopy that resulted in normal findings, according to the written instructions provided to them.

Exclusion Criteria:

  • Subject has any condition which, in the opinion of the investigator should preclude participation in the study.
  • Subject had any findings on recent or any previous colonoscopy including benign, and/or hyperplastic polyps of any size. (Note: Tissue biopsies that result in no histopathology findings are acceptable.)
  • Subject has a history or recent diagnosis of CRC or adenoma.
  • Subject has a history of aerodigestive tract cancer.
  • Subject has had a positive fecal occult blood test or FIT within the previous six (6) months.
  • Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease.
  • Subject has had overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding)

  • Subject has a diagnosis or 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.
    • Greater than or equal to (>=)2 first-degree relatives who have been diagnosed with colon cancer. (Note: first-degree relatives include parents, siblings and offspring).
    • One first-degree relative with CRC diagnosed before the age of 60.
    • Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP).
    • Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" of "Lynch Syndrome").
    • Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kun etui

Kohorter og interventioner

Gruppe / kohorte
Average risk patients
Subjects will be men and women, 50-84 years of age, inclusive, each with a screening colonoscopy resulting in normal findings.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sensitivity and Specificity of the Exact CRC diagnostic screening test.
Tidsramme: 10 months
The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms.
10 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Exact Sciences Corporation

Efterforskere

  • Studiestol: Graham Lidgard, PhD, Chief Scientific officer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2011

Primær færdiggørelse (Faktiske)

1. august 2012

Studieafslutning (Faktiske)

1. september 2012

Datoer for studieregistrering

Først indsendt

11. maj 2012

Først indsendt, der opfyldte QC-kriterier

14. maj 2012

Først opslået (Skøn)

17. maj 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. maj 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2015

Sidst verificeret

1. maj 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Exact Sciences 2011-N

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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