NSABP Patient Registry and Biospecimen Profiling Repository
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|ClinicalTrials.gov Identifier: NCT01793805|
Recruitment Status : Unknown
Verified January 2016 by NSABP Foundation Inc.
Recruitment status was: Recruiting
First Posted : February 18, 2013
Last Update Posted : January 20, 2016
|Condition or disease|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||2000 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||NSABP Patient Registry and Biospecimen Profiling Repository|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2016|
|Metastatic Colorectal Cancer Patients|
- To characterize common genetic/molecular profiles associated with colorectal cancer (CRC) [ Time Frame: From start of study through study completion at approximately 6 months ]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 ]
- 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 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793805
|Contact: Diana Gosik, RN, BSfirstname.lastname@example.org|
|Principal Investigator:||Norman Wolmark, MD||NSABP Foundation Inc|