Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
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:
1. 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.
2. 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.
3. 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
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.
4. Comparison of the characteristics of individual markers and panels as discriminators to
those of the established current standard, Fecal Occult Blood test (FOBT).
5. 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.
Observational Model: Case Control, Time Perspective: Cross-Sectional
Dean E Brenner, MD
University of Michigan
United States: Institutional Review Board
|University of Michigan||Ann Arbor, Michigan 48109-0624|
|Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|M.D. Anderson Cancer Center||Houston, Texas 77030|