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Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold

20. juli 2020 oppdatert av: Exact Sciences Corporation
The primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of colorectal cancer (CRC).

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

Subjects will be men and women, 40 years of age or older who are scheduled for a colonoscopy. Approximately 7,500 subjects will be enrolled.

Studietype

Observasjonsmessig

Registrering (Faktiske)

5131

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arizona
      • Tempe, Arizona, Forente stater, 85283
        • CCT Research/Fiel Family and Sports Medicine
    • California
      • Chula Vista, California, Forente stater, 91910
        • GW Research, Inc
      • Huntington Beach, California, Forente stater, 92647
        • Marvel Research, LLC
      • Palm Springs, California, Forente stater, 92262
        • Desert Medical Group Inc
      • San Diego, California, Forente stater, 92103
        • Great Lakes Medical Research, LLC
    • Connecticut
      • Hartford, Connecticut, Forente stater, 06016
        • Connecticut Clinical Research Institute, LLC
      • New Haven, Connecticut, Forente stater, 06520
        • Yale University
    • Florida
      • Tampa, Florida, Forente stater, 33614
        • Guardian Angel Research Center
    • Illinois
      • Oak Lawn, Illinois, Forente stater, 60453
        • DM Clinical Research/Southwest Gastroenterology
    • Indiana
      • Batesville, Indiana, Forente stater, 47006
        • Margaret Mary Health
      • Evansville, Indiana, Forente stater, 47725
        • Deaconess Clinic-Mt. Pleasant
      • Newburgh, Indiana, Forente stater, 47630
        • Deaconess Clinic-Gateway
    • Louisiana
      • Metairie, Louisiana, Forente stater, 70006
        • New Orleans Research Institute
      • Monroe, Louisiana, Forente stater, 71201
        • Delta Research Partners
      • Shreveport, Louisiana, Forente stater, 71105
        • Louisiana Research Center, LLC
    • Maryland
      • Elkridge, Maryland, Forente stater, 21075
        • Centennial Medical Group
      • Rockville, Maryland, Forente stater, 20850
        • Capitol Research
    • Michigan
      • East Lansing, Michigan, Forente stater, 48823
        • Great Lakes Medical Research, LLC
    • Minnesota
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic
    • New Jersey
      • Egg Harbor Township, New Jersey, Forente stater, 08234
        • AGA Clinical Research Associates, LLC
    • New York
      • New Hyde Park, New York, Forente stater, 11040
        • Digestive Disease Care, PC
    • North Carolina
      • Asheville, North Carolina, Forente stater, 28801
        • Digestive Health Partners, PA
      • Charlotte, North Carolina, Forente stater, 28207
        • Charlotte Gastroenterology and Hepatology, LLC
      • Wilmington, North Carolina, Forente stater, 28403
        • Trial Management Associates, LLC
    • Ohio
      • Beachwood, Ohio, Forente stater, 44122
        • Great Lakes Medical Research
      • Massillon, Ohio, Forente stater, 44647
        • Family Practice Center of Wooster, Inc./Clinical Trial Developers
      • Mentor, Ohio, Forente stater, 44060
        • Great Lakes Gastroenterology Research, LLC
      • Westlake, Ohio, Forente stater, 44145
        • Great Lakes Medical Research, LLC
      • Wooster, Ohio, Forente stater, 44691
        • Comprehensive Internal Medicine, Inc
    • Pennsylvania
      • Erie, Pennsylvania, Forente stater, 16506
        • Great Lakes Medical Research
      • Harrisburg, Pennsylvania, Forente stater, 17110
        • Susquehanna Research Group
    • Tennessee
      • Union City, Tennessee, Forente stater, 38261
        • Great Lakes Medical Research, LLC
    • Texas
      • Austin, Texas, Forente stater, 78726
        • MediSync Clinical Research
      • Cypress, Texas, Forente stater, 77429
        • Northside Gastroenterology
      • Houston, Texas, Forente stater, 77017
        • Vilo Research Group, Inc
      • Houston, Texas, Forente stater, 77024
        • Digestive Health Associates
      • Magnolia, Texas, Forente stater, 77355
        • DM Clinical Research/PCP For Life
    • Virginia
      • Lynchburg, Virginia, Forente stater, 24502
        • Blue Ridge Medical Research
      • Suffolk, Virginia, Forente stater, 23434
        • Virginia Gastroenterology Institute
    • Washington
      • Wenatchee, Washington, Forente stater, 98801
        • Wenatchee Valley Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Subjects will be men and women, 40 years of age or older who are scheduled for a colonoscopy. Approximately 7,500 subjects will be enrolled.

Beskrivelse

Inclusion Criteria:

  • Subject is male or female, 40 years of age or older.
  • Subject is at average or increased risk for development of CRC.
  • Subject presents for screening or surveillance colonoscopy.
  • Subject has no symptoms that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
  • Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria:

  • Any previous cancer diagnosis (with the exceptions of basal cell or squamous cell skin cancers) and/or cancer related treatment (e.g. chemotherapy, immunotherapy, radiation, and/or surgery) within the past 5 years.

  • Subject has a diagnosis or personal history of any of the following conditions, including:

    1. Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome).
    2. Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
    3. Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis and Familial Hyperplastic Polyposis.

  • Subject has a family history of:

    1. Familial adenomatous polyposis (also referred to as "FAP").
    2. Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
  • Subjects with Cronkhite-Canada Syndrome.
  • IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
  • Subject has any condition that in the opinion of the Investigator should preclude participation in the study

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Average CRC Risk Group
Stool sample collection and blood draw in men and women aged 40 and older with average CRC risk undergoing a standard of care colonoscopy procedure
Increased CRC Risk Group
Stool sample collection and blood draw in men and women aged 40 and older with increased CRC risk undergoing a standard of care colonoscopy procedure

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Stool-based biomarkers associated with genetic and epigenetic alterations
Tidsramme: Stool sample will be collected prior to initiation of bowel preparation for colonoscopy.
The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in stool from subjects at average risk or increased risk for development of colorectal cancer at the pre-intervention stage.
Stool sample will be collected prior to initiation of bowel preparation for colonoscopy.
Blood-based biomarkers associated with genetic and epigenetic alterations.
Tidsramme: Point in time blood collection (1 day) at enrollment.
The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects at average risk or increased risk for development of colorectal cancer at the pre-intervention stage.
Point in time blood collection (1 day) at enrollment.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Exact Sciences Corporation

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. januar 2019

Primær fullføring (Faktiske)

28. februar 2020

Studiet fullført (Faktiske)

15. mai 2020

Datoer for studieregistrering

Først innsendt

16. januar 2019

Først innsendt som oppfylte QC-kriteriene

25. januar 2019

Først lagt ut (Faktiske)

30. januar 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. juli 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. juli 2020

Sist bekreftet

1. juli 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2018-08

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures and appendices. The study protocol and informed consent form will also be shared.

IPD-delingstidsramme

Data will be available from 2 years and ending 4 years after publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.

Tilgangskriterier for IPD-deling

Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will available between 2 and 4 years after publication through the Sponsor.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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Abonnere