Clinical Trial: Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
Brief Summary: Colonoscopy is the current state-of-the-art screening procedure for detecting colorectal cancers. However, compliance with this screening procedure by the public is very low for a variety of reasons. New screening tools are needed to improve detection of colon cancer. Biomarkers from stool, urine, serum, tissue and plasma may provide valuable initial screening tools to sort the population into those that need colonoscopy and those that most likely do not. This is a cross-sectional study of subjects undergoing clinically-indicated colonoscopy or who have diagnosed colorectal cancer who are willing to provide biospecimens.
Detailed Summary:
In recognition of the fact that novel potential biomarkers are continually being identified and will need to be validated in a rapid, efficient and scientifically rigorous manner, the NCI has made an enormous commitment to the development of a network that will facilitate biomarker development and validation in multiple organ sites. As part of the National Cancer Institute-funded Early Detection Research Network (EDRN), the Great Lakes-New England Clinical Epidemiological Center (GLNE CEC) proposes a research study that validates potential molecular markers ("biomarkers") for the detection of precancerous and cancerous conditions and cancer risk assessment. Although examples of such biomarkers are currently in clinical use (i.e. CEA, CA-125), there are limitations to all of them. Our consortium focuses on gastrointestinal neoplasia. The goals of this phase of the proposed research are:
- Assessment of the utility of individual stool-based, serum-based and urine-based biomarkers for discriminating between patients with adenocarcinomas, patients with adenomas, patients without adenomas and normal subjects.
- Assessment of the utility of individual stool-based, serum-based and urine-based biomarkers for detecting indicators of carcinogenesis known to be present or not present in adenomas, adenocarcinomas, and normal mucosa.
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Construction of a panel of markers from those considered in Objectives 1 and 2 to discriminate, under a number of assumptions concerning prevalence and cost of misclassification, between:
a Subjects with normal colons versus patients without adenomas, patients with adenomas and patients with cancers; b Subjects with normal colons, patients without adenom
Sponsor: University of Michigan
Current Primary Outcome:
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Information By: University of Michigan
Dates:
Date Received: February 12, 2009
Date Started: December 2005
Date Completion:
Last Updated: March 15, 2011
Last Verified: March 2011
