Study Stopped
Changes in development plan
Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers
1 other identifier
observational
397
2 countries
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2014
Typical duration for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 17, 2015
CompletedFirst Posted
Study publicly available on registry
July 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedApril 6, 2018
April 1, 2018
2.4 years
July 17, 2015
April 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To provide stool and blood specimens to assess new markers for the detection of CRC
33 months
Secondary Outcomes (3)
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 stool and blood specimens for a biorepository for future cancer-related diagnostic test development
33 months
To provide quality control material for use in assessing performance of developed assays
33 months
Study Arms (1)
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.
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
John D. Homan, MD
Newport Beach, California, 92663, United States
Medical Research Center of Connecticut
Hamden, Connecticut, 06518, United States
Gulf Coast Research Group, LLC
Holiday, Florida, 34691, United States
Endoscopic Research, Inc.
Orlando, Florida, 32803, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Colon and Rectal Surgery Associates
Metairie, Louisiana, 70001, United States
New Orleans Research Institute
Metairie, Louisiana, 70006, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71103, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Commonwealth Clinical Studies
Brockton, Massachusetts, 02302, United States
DBA Boone Hospital Center
Columbia, Missouri, 65201, United States
Sundance Clinical Research, LLC
St Louis, Missouri, 63141, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, 28801, United States
Cumberland Research Associates, LLC
Fayetteville, North Carolina, 28304, United States
Northwest Gastroenterology Clinic, LLC
Portland, Oregon, 97210, United States
Main Line Gastroenterology Associates
Malvern, Pennsylvania, 19355, United States
Radiant Research, Inc.
Anderson, South Carolina, 29621, United States
Gastro One
Germantown, Tennessee, 38138, United States
Blue Ridge Medical Researcj
Lynchburg, Virginia, 24502, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Forzani & MacPhali Colon Cancer Screening Centre
Calgary, Alberta, T2N 4Z6, Canada
Biospecimen
Provide anonymous, clinically characterized specimens and blood samples for bio-repository for future colorectal cancer-related test development.
MeSH Terms
Conditions
Study Officials
- STUDY CHAIR
Michael Domanico
Exact Sciences
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2015
First Posted
July 21, 2015
Study Start
October 1, 2014
Primary Completion
March 1, 2017
Study Completion
September 1, 2017
Last Updated
April 6, 2018
Record last verified: 2018-04