Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies
NCT ID: NCT01260168
Last Updated: 2015-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
435 participants
OBSERVATIONAL
2010-10-31
2013-11-30
Brief Summary
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Another objective is to provide anonymous, clinically characterized specimens for a bio-repository for future colorectal cancer-related test development.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
Study Groups
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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 an intact pre-malignant colorectal lesion large enough to require surgical excision or complex colonoscopic polypectomy.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
90 Years
ALL
No
Sponsors
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Exact Sciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Graham Lidgard, PhD
Role: STUDY_CHAIR
Chief Scientific Officer
Locations
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Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Clinical Research Associates
Huntsville, Alabama, United States
Atlanta Gastroenterology
Atlanta, Georgia, United States
Jesse Brown VA
Chicago, Illinois, United States
Rush University Gastroenterologists
Chicago, Illinois, United States
Stroger Cook County
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Rockford Gastroenterology Associates, Ltd
Rockford, Illinois, United States
Gastroenterology Associates
Baton Rouge, Louisiana, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Commonwealth Clinical Studies
Brockton, Massachusetts, United States
Long Island Gastrointestinal Group
Great Neck, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Asheville Gastroenterology
Asheville, North Carolina, United States
Southern Gastroenterology Associates
New Bern, North Carolina, United States
Northwest Gastroenterology Clinic, LLC
Portland, Oregon, United States
Gastro One
Germantown, Tennessee, United States
Digestive Health Specialists
Tyler, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
University of Calgary
Calgary, Alberta, Canada
Countries
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References
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Lidgard GP, Domanico MJ, Bruinsma JJ, Light J, Gagrat ZD, Oldham-Haltom RL, Fourrier KD, Allawi H, Yab TC, Taylor WR, Simonson JA, Devens M, Heigh RI, Ahlquist DA, Berger BM. Clinical performance of an automated stool DNA assay for detection of colorectal neoplasia. Clin Gastroenterol Hepatol. 2013 Oct;11(10):1313-8. doi: 10.1016/j.cgh.2013.04.023. Epub 2013 Apr 29.
Other Identifiers
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Exact Sciences 2010-A
Identifier Type: -
Identifier Source: org_study_id
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