Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
|ClinicalTrials.gov Identifier: NCT00843375|
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : March 16, 2011
|Condition or disease|
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.
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 adenomas and patients with adenomas, versus subjects with cancers; c Subjects with normal colons versus patients without and patients with adenomas versus patients with cancers.
- Comparison of the characteristics of individual markers and panels as discriminators to those of the established current standard, Fecal Occult Blood test (FOBT).
- Development of a bank of stool samples linked to serum, tissue, urine and clinical data from patients with colorectal cancer, adenomas and normal controls for validation of stool-based markers that may be developed in the future.
To meet our goals the investigators propose to collect stool, rectal mucus, serum, plasma, and urine samples from 800 subjects (200 colorectal cancers, 200 adenomas, 200 higher risk normals and 200 normal colons for controls). The stool samples will be assayed for stool-based biomarkers. EDRN Common Data Elements (CDEs) will be completed by the recruiting sites and provided for the laboratories developing the assay.
|Study Type :||Observational|
|Actual Enrollment :||695 participants|
|Observational Model:||Case Control|
|Official Title:||Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas|
|Study Start Date :||December 2005|
|Primary Completion Date :||April 2010|
|Study Completion Date :||April 2010|
Subjects who have had a colonoscopy and no adenomas or cancer was found.
Subjects who had an adenoma found on colonoscopy. All samples must be collected before the adenoma is removed.
Subjects who have confirmed colorectal carcinoma. All samples must be collected before the cancer is removed.
High Risk Normals
Subjects who had a colonoscopy without adenomas or cancer AND have a history of adenomas, colorectal cancer (greater than 3 years ago) or a family history of cancer or adenomas.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843375
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Texas|
|M.D. Anderson Cancer Center|
|Houston, Texas, United States|
|St. Michael's Hospital|
|Toronto, Ontario, Canada|
|Principal Investigator:||Dean E Brenner, MD||University of Michigan|