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Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers

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ClinicalTrials.gov Identifier: NCT02503631
Recruitment Status : Terminated (Changes in development plan)
First Posted : July 21, 2015
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment
Colorectal Neoplasms Digestive System Diseases Colonic Diseases Colorectal Cancer Device: Stool Sample Collection Kit

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 397 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers
Actual Study Start Date : October 2014
Actual Primary Completion Date : March 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Device: Stool Sample Collection Kit
Stool sample collection kit




Primary Outcome Measures :
  1. To provide stool and blood specimens to assess new markers for the detection of CRC [ Time Frame: 33 months ]

Secondary Outcome Measures :
  1. 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.) [ Time Frame: 33 months ]
  2. To provide stool and blood specimens for a biorepository for future cancer-related diagnostic test development [ Time Frame: 33 months ]
  3. To provide quality control material for use in assessing performance of developed assays [ Time Frame: 33 months ]

Biospecimen Retention:   Samples With DNA
Provide anonymous, clinically characterized specimens and blood samples for bio-repository for future colorectal cancer-related test development.


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503631


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Locations
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United States, California
John D. Homan, MD
Newport Beach, California, United States, 92663
United States, Connecticut
Medical Research Center of Connecticut
Hamden, Connecticut, United States, 06518
United States, Florida
Gulf Coast Research Group, LLC
Holiday, Florida, United States, 34691
Endoscopic Research, Inc.
Orlando, Florida, United States, 32803
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Louisiana
Colon and Rectal Surgery Associates
Metairie, Louisiana, United States, 70001
New Orleans Research Institute
Metairie, Louisiana, United States, 70006
Louisiana Research Center, LLC
Shreveport, Louisiana, United States, 71103
United States, Maryland
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
Commonwealth Clinical Studies
Brockton, Massachusetts, United States, 02302
United States, Missouri
DBA Boone Hospital Center
Columbia, Missouri, United States, 65201
Sundance Clinical Research, LLC
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Quality Clinical Research, Inc.
Omaha, Nebraska, United States, 68114
United States, North Carolina
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, United States, 28801
Cumberland Research Associates, LLC
Fayetteville, North Carolina, United States, 28304
United States, Oregon
Northwest Gastroenterology Clinic, LLC
Portland, Oregon, United States, 97210
United States, Pennsylvania
Main Line Gastroenterology Associates
Malvern, Pennsylvania, United States, 19355
United States, South Carolina
Radiant Research, Inc.
Anderson, South Carolina, United States, 29621
United States, Tennessee
Gastro One
Germantown, Tennessee, United States, 38138
United States, Virginia
Blue Ridge Medical Researcj
Lynchburg, Virginia, United States, 24502
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States, 23502
Canada, Alberta
Forzani & MacPhali Colon Cancer Screening Centre
Calgary, Alberta, Canada, T2N 4Z6
Sponsors and Collaborators
Exact Sciences Corporation
Investigators
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Study Chair: Michael Domanico Exact Sciences

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Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT02503631     History of Changes
Other Study ID Numbers: 2014-02
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Keywords provided by Exact Sciences Corporation:
Cancer
Colorectal Cancer
Neoplasm
Colorectal Neoplasm
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases
Additional relevant MeSH terms:
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Colorectal Neoplasms
Colonic Diseases
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rectal Diseases