Trial record 1 of 1 for:    MPR-1
Previous Study | Return to List | Next Study

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
  Purpose

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.


Condition
Colorectal Cancer

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

Resource links provided by NLM:


Further study details as provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 2000
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)
Groups/Cohorts
Metastatic Colorectal Cancer Patients

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Metastatic colorectal cancer patients.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01793805

Contacts
Contact: Diana Gosik, RN, BS 412-339-5333 diana.gosik@nsabp.org

Locations
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
Sponsors and Collaborators
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Investigators
Principal Investigator: Norman Wolmark, MD NSABP Foundation, Inc.
  More Information

No publications provided

Responsible Party: National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier: NCT01793805     History of Changes
Other Study ID Numbers: NSABP MPR-1
Study First Received: February 11, 2013
Last Updated: January 29, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 23, 2014