About APTB Specimen Bank:
The Adenoma Polyp Tissue Bank (APTB) receives whole blood
from patients enrolled in the Prevention of Sporadic
Colorectal Adenomas with Celecoxib clinical trial.
We have reached our accrual on blood submissions, so we will no
longer be receiving blood specimens
The
objectives of this trial are as follows:
A. To
determine the efficacy and safety of celecoxib versus placebo
in preventing the occurrence of newly detected colorectal
adenomas in subjects at increased risk for colorectal carcinoma.
In addition to incidence, other established risk factors
will be evaluated for their association with occurrence
of new colorectal adenomas, including cancer family history
and adenoma size, histopathologic grade, multiplicity and
location.
Primary assessment of treatment efficacy will be
the reduction in the number of subjects with adenomas at
colonoscopy after Year 1 and Year 3 of study drug use.
Secondary assessments of treatment efficacy will be
1) the number of adenomas 2) the histopathologic grade of
adenomas and 3) the size of adenomas, also measured after
one year and three years of study drug use. These factors
will be incorporated into a risk model for predicting adenoma
occurrence and response to celecoxib.
B.
To determine the efficacy of celecoxib versus placebo in
modulating one or more of a panel of biomarkers for colorectal
cancer at the cellular and molecular level sampled in a
subset of subjects at selective sites at baseline and after
Year 1 and Year 3 of study drug use. These biomarkers will
include measurements of aberrant crypt foci (ACF), proliferation
(index and crypt distribution), apoptosis (index and crypt
distribution), COX expression and activity. If modulation
of one or more mucosal biomarkers occur, we will explore
whether it correlates with the development of incident colorectal
neoplasia (adenomas/carcinomas), thereby attempting to validate
the surrogacy of that biomarker.
C. To develop a specimen bank. Serum and white blood cells
are isolated from whole blood and adenoma tissue blocks
and slides are banked. Banked specimens will become available
for use in correlative science studies at a later point.
This project began in 1999 and will be extended through
2006. The lead principal investigator is Monica M. Bertagnolli,
MD, Brigham and Women's Hospital, Boston, MA, and the APTB Director is Scott Jewell, Ph.D., Department
of Pathology, The Ohio State University. The APTB is supported by the NIH, NCI Division of Cancer Prevention,
in connection with the Strang Cancer Prevention Center,
Cornell University, New York.
