Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold
20. juli 2020 opdateret af: 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).
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret 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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
5131
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arizona
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Tempe, Arizona, Forenede Stater, 85283
- CCT Research/Fiel Family and Sports Medicine
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California
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Chula Vista, California, Forenede Stater, 91910
- GW Research, Inc
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Huntington Beach, California, Forenede Stater, 92647
- Marvel Research, LLC
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Palm Springs, California, Forenede Stater, 92262
- Desert Medical Group Inc
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San Diego, California, Forenede Stater, 92103
- Great Lakes Medical Research, LLC
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Connecticut
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Hartford, Connecticut, Forenede Stater, 06016
- Connecticut Clinical Research Institute, LLC
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New Haven, Connecticut, Forenede Stater, 06520
- Yale University
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Florida
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Tampa, Florida, Forenede Stater, 33614
- Guardian Angel Research Center
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Illinois
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Oak Lawn, Illinois, Forenede Stater, 60453
- DM Clinical Research/Southwest Gastroenterology
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Indiana
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Batesville, Indiana, Forenede Stater, 47006
- Margaret Mary Health
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Evansville, Indiana, Forenede Stater, 47725
- Deaconess Clinic-Mt. Pleasant
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Newburgh, Indiana, Forenede Stater, 47630
- Deaconess Clinic-Gateway
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Louisiana
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Metairie, Louisiana, Forenede Stater, 70006
- New Orleans Research Institute
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Monroe, Louisiana, Forenede Stater, 71201
- Delta Research Partners
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Shreveport, Louisiana, Forenede Stater, 71105
- Louisiana Research Center, LLC
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Maryland
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Elkridge, Maryland, Forenede Stater, 21075
- Centennial Medical Group
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Rockville, Maryland, Forenede Stater, 20850
- Capitol Research
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Michigan
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East Lansing, Michigan, Forenede Stater, 48823
- Great Lakes Medical Research, LLC
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic
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New Jersey
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Egg Harbor Township, New Jersey, Forenede Stater, 08234
- AGA Clinical Research Associates, LLC
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New York
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New Hyde Park, New York, Forenede Stater, 11040
- Digestive Disease Care, PC
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28801
- Digestive Health Partners, PA
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Charlotte, North Carolina, Forenede Stater, 28207
- Charlotte Gastroenterology and Hepatology, LLC
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Wilmington, North Carolina, Forenede Stater, 28403
- Trial Management Associates, LLC
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Ohio
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Beachwood, Ohio, Forenede Stater, 44122
- Great Lakes Medical Research
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Massillon, Ohio, Forenede Stater, 44647
- Family Practice Center of Wooster, Inc./Clinical Trial Developers
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Mentor, Ohio, Forenede Stater, 44060
- Great Lakes Gastroenterology Research, LLC
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Westlake, Ohio, Forenede Stater, 44145
- Great Lakes Medical Research, LLC
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Wooster, Ohio, Forenede Stater, 44691
- Comprehensive Internal Medicine, Inc
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Pennsylvania
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Erie, Pennsylvania, Forenede Stater, 16506
- Great Lakes Medical Research
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Harrisburg, Pennsylvania, Forenede Stater, 17110
- Susquehanna Research Group
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Tennessee
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Union City, Tennessee, Forenede Stater, 38261
- Great Lakes Medical Research, LLC
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Texas
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Austin, Texas, Forenede Stater, 78726
- MediSync Clinical Research
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Cypress, Texas, Forenede Stater, 77429
- Northside Gastroenterology
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Houston, Texas, Forenede Stater, 77017
- Vilo Research Group, Inc
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Houston, Texas, Forenede Stater, 77024
- Digestive Health Associates
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Magnolia, Texas, Forenede Stater, 77355
- DM Clinical Research/PCP For Life
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Virginia
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Lynchburg, Virginia, Forenede Stater, 24502
- Blue Ridge Medical Research
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Suffolk, Virginia, Forenede Stater, 23434
- Virginia Gastroenterology Institute
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Washington
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Wenatchee, Washington, Forenede Stater, 98801
- Wenatchee Valley Hospital
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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
40 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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:
- Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome).
- Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
- 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:
- Familial adenomatous polyposis (also referred to as "FAP").
- 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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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
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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
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Stool-based biomarkers associated with genetic and epigenetic alterations
Tidsramme: Stool sample will be collected prior to initiation of bowel preparation for colonoscopy.
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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.
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Stool sample will be collected prior to initiation of bowel preparation for colonoscopy.
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Blood-based biomarkers associated with genetic and epigenetic alterations.
Tidsramme: Point in time blood collection (1 day) at enrollment.
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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.
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Point in time blood collection (1 day) at enrollment.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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 (Faktiske)
3. januar 2019
Primær færdiggørelse (Faktiske)
28. februar 2020
Studieafslutning (Faktiske)
15. maj 2020
Datoer for studieregistrering
Først indsendt
16. januar 2019
Først indsendt, der opfyldte QC-kriterier
25. januar 2019
Først opslået (Faktiske)
30. januar 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. juli 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. juli 2020
Sidst verificeret
1. juli 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2018-08
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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.
IPD-delingsadgangskriterier
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 Understøttende informationstype
- STUDY_PROTOCOL
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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 .