Trial record 1 of 1 for:    MPR-1
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NSABP Patient Registry and Biospecimen Profiling Repository

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Surgical Adjuvant Breast and Bowel Project (NSABP)
Sponsor:
Information provided by (Responsible Party):
National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier:
NCT01793805
First received: February 11, 2013
Last updated: January 29, 2014
Last verified: January 2014

February 11, 2013
January 29, 2014
February 2013
June 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01793805 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
NSABP Patient Registry and Biospecimen Profiling Repository
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.

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
2 Years
Retention:   Samples With DNA
Description:

Tissue blocks from the primary tumor site and an uninvolved margin of resection (normal tissue).

Non-Probability Sample

Metastatic colorectal cancer patients.

Colorectal Cancer
Not Provided
Metastatic Colorectal Cancer Patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The patient must have a diagnosis of metastatic colorectal adenocarcinoma.
  • Representative formalin-fixed paraffin-embedded (FFPE) tissue blocks from the primary colorectal tumor surgery with corresponding pathology report must be available for release by the local pathology department (an adequate amount of tumor tissue is required for analysis). If available for release, a separate FFPE tissue block from an uninvolved margin of colorectal resection (normal tissue) is also requested.
  • The patient must have a life-expectancy of greater than or equal to 6 months.

Exclusion Criteria:

  • History of non-CRC malignancy unless the patient is considered by the physician to be disease-free and at low risk for recurrence.
  • Known comorbid medical conditions that would preclude investigational treatment (e.g., active hepatitis B or C; symptomatic cardiac disease; renal insufficiency; bone marrow impairment).
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude investigational treatment.
  • Colonoscopy biopsies or diagnostic core biopsy procedures without surgery or resection.
Both
18 Years and older
No
Contact: Diana Gosik, RN, BS 412-339-5333 diana.gosik@nsabp.org
United States
 
NCT01793805
NSABP MPR-1
No
National Surgical Adjuvant Breast and Bowel Project (NSABP)
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Not Provided
Principal Investigator: Norman Wolmark, MD NSABP Foundation, Inc.
National Surgical Adjuvant Breast and Bowel Project (NSABP)
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP