Spots Global Cancer Trial Database for Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers
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Trial Identification
Brief Title: Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers
Official Title: Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers
Study ID: NCT02503631
Interventions
Study Description
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.
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.
Eligibility
Minimum Age: 40 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
John D. Homan, MD, Newport Beach, California, United States
Medical Research Center of Connecticut, Hamden, Connecticut, United States
Gulf Coast Research Group, LLC, Holiday, Florida, United States
Endoscopic Research, Inc., Orlando, Florida, United States
Rush University Medical Center, Chicago, Illinois, United States
Colon and Rectal Surgery Associates, Metairie, Louisiana, United States
New Orleans Research Institute, Metairie, Louisiana, United States
Louisiana Research Center, LLC, Shreveport, Louisiana, United States
Chevy Chase Clinical Research, Chevy Chase, Maryland, United States
Commonwealth Clinical Studies, Brockton, Massachusetts, United States
DBA Boone Hospital Center, Columbia, Missouri, United States
Sundance Clinical Research, LLC, Saint Louis, Missouri, United States
Quality Clinical Research, Inc., Omaha, Nebraska, United States
Asheville Gastroenterology Associates, PA, Asheville, North Carolina, United States
Cumberland Research Associates, LLC, Fayetteville, North Carolina, United States
Northwest Gastroenterology Clinic, LLC, Portland, Oregon, United States
Main Line Gastroenterology Associates, Malvern, Pennsylvania, United States
Radiant Research, Inc., Anderson, South Carolina, United States
Gastro One, Germantown, Tennessee, United States
Blue Ridge Medical Researcj, Lynchburg, Virginia, United States
Digestive and Liver Disease Specialists, Norfolk, Virginia, United States
Forzani & MacPhali Colon Cancer Screening Centre, Calgary, Alberta, Canada
Contact Details
Name: Michael Domanico
Affiliation: Exact Sciences
Role: STUDY_CHAIR
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