NSABP Patient Registry and Biospecimen Profiling Repository
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 Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||2 Years|
|Official Title:||NSABP Patient Registry and Biospecimen Profiling Repository|
- To characterize common genetic/molecular profiles associated with colorectal cancer (CRC) [ Time Frame: From start of study through study completion at approximately 6 months ] [ Designated as safety issue: No ]This is a living registry with no end date provided continued funding.
- To identify subpopulations of registry patients on the basis of their molecular profiles that may be eligible for participation in available NSABP clinical trials involving novel agents [ Time Frame: From start of study through study completion at approximately 6 months ] [ Designated as safety issue: No ]
- To conduct further analysis of tumor samples for the discovery of new potential targets and mechanisms of drug resistance [ Time Frame: From start of study through study completion at approximately 6 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Tissue blocks from the primary tumor site and an uninvolved margin of resection (normal tissue).
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
|Metastatic Colorectal Cancer Patients|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01793805
|Contact: Diana Gosik, RN, BSfirstname.lastname@example.org|
|United States, Florida|
|University of Florida||Recruiting|
|Gainesville, Florida, United States, 32610|
|MD Anderson Cancer Center Orlando||Recruiting|
|Orlando, Florida, United States, 32806|
|United States, Idaho|
|St. Luke's Mountain States Tumor Institute - Boise||Recruiting|
|Boise, Idaho, United States, 83712|
|United States, Pennsylvania|
|Thomas Jefferson University Hospital||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Norman Wolmark, MD||NSABP Foundation, Inc.|