This is a study to collect and analyze tissue specimens from metastatic colorectal cancer
(mCRC) patients for the development of a molecularly profiled tissue repository for the
primary purpose of maintaining a patient registry for future clinical trials based on the
molecular profile of the tumors. The main purpose of testing these tissue specimens is to
identify genetic alterations or biomarkers associated with colorectal cancer such that if
new agent(s) become available, particularly those that target these genetic
alterations/biomarkers, participants may be offered the opportunity to take part in a
National Surgical Adjuvant Breast and Bowel Project (NSABP) treatment protocol.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01793805.
Locations matching your search criteria
United States
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)Status: Active
Name Not Available
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.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationNSABP Foundation Inc
