Status:
COMPLETED
Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies
Lead Sponsor:
Exact Sciences Corporation
Conditions:
Colorectal Neoplasms
Digestive System Diseases
Eligibility:
All Genders
40-90 years
Brief Summary
The objective of this study is to confirm the sensitivity of a stool DNA test for detection of colorectal cancer and pre-cancer. Another objective is to provide anonymous, clinically characterized sp...
Detailed Description
Patients who have been recently diagnosed with colo-rectal cancer or pre-cancer will be asked to submit a stool sample(s)(at least 7 days AFTER colonoscopy) and will have the option of submitting bloo...
Eligibility Criteria
Inclusion
- 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 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.
- 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
- Subject has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung, esophagus, stomach, or pancreatic cancer).
- Subject has a history of any inflammatory bowel disease.
- Subject has familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch) syndrome, or other hereditary cancer syndromes.
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
435 Patients enrolled
Trial Details
Trial ID
NCT01260168
Start Date
October 1 2010
End Date
November 1 2013
Last Update
May 13 2015
Active Locations (21)
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1
Achieve Clinical Research, LLC
Birmingham, Alabama, United States, 35216
2
Clinical Research Associates
Huntsville, Alabama, United States, 35801
3
Atlanta Gastroenterology
Atlanta, Georgia, United States, 30308
4
Jesse Brown VA
Chicago, Illinois, United States, 60612