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.
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.
Study Type
OBSERVATIONAL
Enrollment
397
Stool sample collection kit
John D. Homan, MD
Newport Beach, California, United States
To provide stool and blood specimens to assess new markers for the detection of CRC
Time frame: 33 months
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.)
Time frame: 33 months
To provide stool and blood specimens for a biorepository for future cancer-related diagnostic test development
Time frame: 33 months
To provide quality control material for use in assessing performance of developed assays
Time frame: 33 months
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