NSABP Patient Registry and Biospecimen Profiling Repository
Tissue blocks from the primary tumor site and an uninvolved margin of resection (normal
tissue) from consenting patients will be submitted and stored at the NSABP Division of
Pathology, in the NSABP Biospecimen Profiling Repository. Tissue specimens will be used to
profile molecular characteristics, including actionable mutations most commonly identified
in colorectal cancer. Specimens may be further interrogated by other methods to discover
additional mechanisms and targetable genetic alterations that may predict sensitivity or
resistance to drug therapies.
The repository will be populated, maintained, and analyzed through continuous patient
recruitment. Patient tumor specimens will be interrogated to characterize an individual's
molecular profile. At a future date for discovery purposes, the normal tissue may be
profiled for comparison with the profile of the tumor tissue. NSABP will hold a database
with molecular profiles and relevant patient information. As agents become available for
clinical study, particularly those matching specified profiles, the treating physician will
be contacted so that the patient may be offered participation in that trial via a separate
consent process. Each NSABP trial will have a defined molecular profile for entry which
will be specific to the agent(s) under study. The MPR-1 patient registry and tissue
repository and all treatment protocols associated with MPR-1 are being developed as part of
the NSABP Oncology-Genome Assessment Guided Medicine (N-GAMe) Program.
This registry and repository platform uses a translational science approach for more
personalized therapy for patients with mCRC. This analysis provides an individual molecular
profile in an attempt to direct each patient's treatment based on the pattern of genetic
alterations. These efforts also may aid in the discovery of with or without new gene
targets for future drug development.
Approximately 1000-2000 tumor (with or without) normal tissue specimens from living mCRC
patients will be collected, stored, and analyzed as part of this biospecimen repository. It
is anticipated that 200-400 participants will be registered within the first year.
Observational [Patient Registry]
Observational Model: Cohort, Time Perspective: Prospective
To characterize common genetic/molecular profiles associated with colorectal cancer (CRC)
This is a living registry with no end date provided continued funding.
From start of study through study completion at approximately 6 months
Norman Wolmark, MD
NSABP Foundation, Inc.
United States: Institutional Review Board
|MD Anderson Cancer Center Orlando||Orlando, Florida 32806|
|St. Luke's Mountain States Tumor Institute - Boise||Boise, Idaho 83712-6297|
|University of Florida||Gainesville, Florida 32610-0277|
|Thomas Jefferson University Hospital||Philadelphia, Pennsylvania 19131|