Colon Cancer Clinical Trial
Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers
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.
Full 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 Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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There are 22 Locations for this study
Newport Beach California, 92663, United States
Hamden Connecticut, 06518, United States
Holiday Florida, 34691, United States
Orlando Florida, 32803, United States
Chicago Illinois, 60612, United States
Metairie Louisiana, 70001, United States
Metairie Louisiana, 70006, United States
Shreveport Louisiana, 71103, United States
Chevy Chase Maryland, 20815, United States
Brockton Massachusetts, 02302, United States
Columbia Missouri, 65201, United States
Saint Louis Missouri, 63141, United States
Omaha Nebraska, 68114, United States
Asheville North Carolina, 28801, United States
Fayetteville North Carolina, 28304, United States
Portland Oregon, 97210, United States
Malvern Pennsylvania, 19355, United States
Anderson South Carolina, 29621, United States
Germantown Tennessee, 38138, United States
Lynchburg Virginia, 24502, United States
Norfolk Virginia, 23502, United States
Calgary Alberta, T2N 4, Canada
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