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Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies

12. maj 2015 opdateret af: Exact Sciences Corporation

The objective of this study is to confirm the sensitivity of a stool DNA test for detection of colorectal cancer and pre-cancer.

Another objective is to provide anonymous, clinically characterized specimens for a bio-repository for future colorectal cancer-related test development.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Patients who have been recently diagnosed with colo-rectal cancer or pre-cancer will be asked to submit a stool sample(s)(at least 7 days AFTER colonoscopy) and will have the option of submitting blood and tissue samples for future colo-rectal cancer-related test development.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

435

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35216
        • Achieve Clinical Research, LLC
      • Huntsville, Alabama, Forenede Stater, 35801
        • Clinical Research Associates
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30308
        • Atlanta Gastroenterology
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, Forenede Stater, 60612
        • Jesse Brown VA
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University Gastroenterologists
      • Chicago, Illinois, Forenede Stater, 60612
        • Stroger Cook County
      • Rockford, Illinois, Forenede Stater, 61107
        • Rockford Gastroenterology Associates, Ltd
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70809
        • Gastroenterology Associates
    • Maryland
      • Chevy Chase, Maryland, Forenede Stater, 20815
        • Chevy Chase Clinical Research
    • Massachusetts
      • Brockton, Massachusetts, Forenede Stater, 02302
        • Commonwealth Clinical Studies
    • New York
      • Great Neck, New York, Forenede Stater, 11023
        • Long Island Gastrointestinal Group
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai School of Medicine
    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28801
        • Asheville Gastroenterology
      • New Bern, North Carolina, Forenede Stater, 28562
        • Southern Gastroenterology Associates
    • Oregon
      • Portland, Oregon, Forenede Stater, 97208
        • Northwest Gastroenterology Clinic, LLC
    • Tennessee
      • Germantown, Tennessee, Forenede Stater, 38138
        • Gastro One
    • Texas
      • Tyler, Texas, Forenede Stater, 75701
        • Digestive Health Specialists
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84132
        • University of Utah
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23502
        • Digestive and Liver Disease Specialists

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 til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients who have had colorectal cancer or pre-malignancy confirmed by colonoscopic biopsy-based diagnosis.

Beskrivelse

Inclusion Criteria:

  1. Subject is male or female, 40-90 years of age, inclusive.
  2. Subject has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy and/or ≥1 cm colorectal polyp/adenoma/mass identified on a colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy.
  3. 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:

  1. Subject has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung, esophagus, stomach, or pancreatic cancer).
  2. Subject has a history of any inflammatory bowel disease.
  3. Subject has familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch) syndrome, or other hereditary cancer syndromes.
  4. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

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
Colorectal cancer patients
Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of colorectal cancer (CRC) and/or an intact pre-malignant colorectal lesion large enough to require surgical excision or complex colonoscopic polypectomy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms.
Tidsramme: 12 Months
The diagnostic test under development is a multi-marker stool test for detecting CRC and pre-cancer in a general screening application. The primary objective of this study is to confirm the sensitivity of the optimal DNA marker panel.
12 Months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To collect samples from patients diagnosed with colorectal cancers.
Tidsramme: 12 Months
Residual samples from patients diagnosed with colorectal cancer will be archived for further research intended to help in the diagnosis of cancers. Specimens will be stored up to 10 years in the Sponsor's on-site bio-repository or similar commercial bio-repository contracted by the sponsor.
12 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 2010

Primær færdiggørelse (Faktiske)

1. november 2013

Studieafslutning (Faktiske)

1. november 2013

Datoer for studieregistrering

Først indsendt

6. december 2010

Først indsendt, der opfyldte QC-kriterier

13. december 2010

Først opslået (Skøn)

15. december 2010

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 2010-A

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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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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