Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers
- Conditions
- Colonic DiseasesColorectal CancerColorectal NeoplasmsDigestive System Diseases
- Interventions
- Device: Stool Sample Collection Kit
- Registration Number
- NCT02503631
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 397
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Colorectal cancer patients Stool Sample Collection Kit 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.
- Primary Outcome Measures
Name Time Method To provide stool and blood specimens to assess new markers for the detection of CRC 33 months
- Secondary Outcome Measures
Name Time Method 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.) 33 months To provide quality control material for use in assessing performance of developed assays 33 months To provide stool and blood specimens for a biorepository for future cancer-related diagnostic test development 33 months
Trial Locations
- Locations (22)
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
DBA Boone Hospital Center
🇺🇸Columbia, Missouri, United States
Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
John D. Homan, MD
🇺🇸Newport Beach, California, United States
Asheville Gastroenterology Associates, PA
🇺🇸Asheville, North Carolina, United States
New Orleans Research Institute
🇺🇸Metairie, Louisiana, United States
Sundance Clinical Research, LLC
🇺🇸Saint Louis, Missouri, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Colon and Rectal Surgery Associates
🇺🇸Metairie, Louisiana, United States
Commonwealth Clinical Studies
🇺🇸Brockton, Massachusetts, United States
Medical Research Center of Connecticut
🇺🇸Hamden, Connecticut, United States
Gulf Coast Research Group, LLC
🇺🇸Holiday, Florida, United States
Radiant Research, Inc.
🇺🇸Anderson, South Carolina, United States
Cumberland Research Associates, LLC
🇺🇸Fayetteville, North Carolina, United States
Main Line Gastroenterology Associates
🇺🇸Malvern, Pennsylvania, United States
Forzani & MacPhali Colon Cancer Screening Centre
🇨🇦Calgary, Alberta, Canada
Gastro One
🇺🇸Germantown, Tennessee, United States
Blue Ridge Medical Researcj
🇺🇸Lynchburg, Virginia, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
Endoscopic Research, Inc.
🇺🇸Orlando, Florida, United States
Northwest Gastroenterology Clinic, LLC
🇺🇸Portland, Oregon, United States
Quality Clinical Research, Inc.
🇺🇸Omaha, Nebraska, United States