Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers
4. april 2018 opdateret af: Exact Sciences Corporation
The primary objective of this study is to obtain de-identified, clinically characterized, stool and plasma specimens for use in assessing new markers for the detection of neoplasms of the digestive tract.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a multi-site, prospective sample collection study. Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of CRC and/or a pre-malignant colorectal lesion with large enough residual lesion to require subsequent surgical excision or complex colonoscopic polypectomy.
One stool sample from approximately 300 subjects will be collected in this study. A blood sample will also be collected from subjects.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
397
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alberta
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Calgary, Alberta, Canada, T2N 4Z6
- Forzani & MacPhali Colon Cancer Screening Centre
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California
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Newport Beach, California, Forenede Stater, 92663
- John D. Homan, MD
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Connecticut
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Hamden, Connecticut, Forenede Stater, 06518
- Medical Research Center of Connecticut
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Florida
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Holiday, Florida, Forenede Stater, 34691
- Gulf Coast Research Group, LLC
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Orlando, Florida, Forenede Stater, 32803
- Endoscopic Research, Inc.
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Rush University Medical Center
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Louisiana
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Metairie, Louisiana, Forenede Stater, 70006
- New Orleans Research Institute
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Metairie, Louisiana, Forenede Stater, 70001
- Colon and Rectal Surgery Associates
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Shreveport, Louisiana, Forenede Stater, 71103
- Louisiana Research Center, LLC
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Maryland
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Chevy Chase, Maryland, Forenede Stater, 20815
- Chevy Chase Clinical Research
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Massachusetts
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Brockton, Massachusetts, Forenede Stater, 02302
- Commonwealth Clinical Studies
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Missouri
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Columbia, Missouri, Forenede Stater, 65201
- DBA Boone Hospital Center
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Saint Louis, Missouri, Forenede Stater, 63141
- Sundance Clinical Research, LLC
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68114
- Quality Clinical Research, Inc.
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28801
- Asheville Gastroenterology Associates, PA
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Fayetteville, North Carolina, Forenede Stater, 28304
- Cumberland Research Associates, LLC
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Oregon
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Portland, Oregon, Forenede Stater, 97210
- Northwest Gastroenterology Clinic, LLC
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Pennsylvania
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Malvern, Pennsylvania, Forenede Stater, 19355
- Main Line Gastroenterology Associates
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South Carolina
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Anderson, South Carolina, Forenede Stater, 29621
- Radiant Research, Inc.
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Tennessee
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Germantown, Tennessee, Forenede Stater, 38138
- Gastro One
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Virginia
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Lynchburg, Virginia, Forenede Stater, 24502
- Blue Ridge Medical Researcj
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Norfolk, Virginia, Forenede Stater, 23502
- Digestive and Liver Disease Specialists
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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 til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of CRC and/or a pre-malignant colorectal lesion with large enough residual lesion to require subsequent surgical excision or complex colonoscopic polypectomy.
Beskrivelse
Inclusion Criteria:
- Subject is male or female, 40-90 years of age, inclusive.
- Subject has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or colorectal polyp/adenoma/mass that is equal or larger than 1 cm in pre-enrollment colonoscopy with residual lesion in the colon of sufficient size to require additional surgical excision or complex colonoscopic polypectomy.
- Subject understands the study procedures and is able to provided informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Exclusion Criteria:
- Subject has actively bleeding hemorrhoids (blood on toilet paper or bright red blood clots in the toilet bowel during bowel movement).
- 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 |
Intervention / Behandling |
|---|---|
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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 a pre-malignant colorectal lesion with large enough residual lesion to require subsequent surgical excision or complex colonoscopic polypectomy.
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Stool sample collection kit
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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To provide stool and blood specimens to assess new markers for the detection of CRC
Tidsramme: 33 months
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33 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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To provide stool and blood specimens for use as controls when assessing new markers for the detection of neoplasms in other locations within the digestive tract (esophagus, stomach, pancreas, etc.)
Tidsramme: 33 months
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33 months
|
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To provide stool and blood specimens for a biorepository for future cancer-related diagnostic test development
Tidsramme: 33 months
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33 months
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To provide quality control material for use in assessing performance of developed assays
Tidsramme: 33 months
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33 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Michael Domanico, Exact Sciences
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)
1. oktober 2014
Primær færdiggørelse (Faktiske)
1. marts 2017
Studieafslutning (Faktiske)
1. september 2017
Datoer for studieregistrering
Først indsendt
17. juli 2015
Først indsendt, der opfyldte QC-kriterier
17. juli 2015
Først opslået (Skøn)
21. juli 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. april 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. april 2018
Sidst verificeret
1. april 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2014-02
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