Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers

Official Title

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.

Trial Description

Primary Outcome:

  • To provide stool specimens to assess new markers for the detection of CRC
Secondary Outcome:
  • To provide stool 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.)
  • To provide stool specimens for a biorepository for future cancer-related diagnostic test development
  • To provide quality control material for use in assessing performance of developed assays
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. Up to three stool samples from approximately 300 subjects will be collected in this study. A blood sample may also be collected from subjects, although the blood sample collection is optional to be enrolled in the study.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society