Official Title
Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
Summary:
Colon cancer is the second most common cancer in men and women. It is a disease that can be
prevented if it is found early. Colonoscopy is still the best screening tool for colon cancer
and the polyps that turn into colon cancer. However, due to a variety of factors, including
affordability, time, and age, not all patients are able to be screened. Researchers are
working on other options for early detection that are as accurate as colonoscopy.
The purpose of this study if to determine if stool or blood can be used to detect colon
cancers as early or earlier than colonoscopy. The researchers plan to use these samples to
learn about specific proteins (also known as biomarkers) that may indicate colon polyps,
colon cancer or an increased risk of developing colon cancer. In order to learn more about
preventing and detecting colon and rectal cancer, we are collecting samples from subjects
with cancer, adenomas, and colonoscopies who may be at risk for polyps.
Trial Description
Primary Outcome:
- Biospecimen Retention: Samples with DNA
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 both at normal and high risk for developing colon
cancer.
·
Construction of a panel of markers from those
considered in Objective 1 to discriminate, under a number of assumptions
concerning prevalence and cost of misclassification, between:
o
Subjects with normal colons versus patients
without adenomas, patients with adenomas and patients with cancers;
o
Subjects with normal colons, patients without
adenomas and patients with adenomas, versus subjects with cancers;
o
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 immunochemical test (FIT).
·
Continued support of a renewal of a bank of
stool samples linked to serum, tissue, 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 build our collection, we propose to collect stool, FIT,
serum, plasma, and tissue samples from 1200 new subjects. Each biomarker will
be analyzed individually and considered as a potential panel marker to be used
for future largescale screening longitudinal trials. (This protocol previously
recruited an additional 682 subjects from January 2006 to June 2010.)
View this trial on ClinicalTrials.gov
