NSABP Patient Registry and Biospecimen Profiling Repository
NCT ID: NCT01793805
Last Updated: 2022-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3232 participants
OBSERVATIONAL
2013-02-28
2022-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Metastatic Colorectal Cancer Patients
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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NSABP Foundation Inc
NETWORK
Responsible Party
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Principal Investigators
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Norman Wolmark, MD
Role: PRINCIPAL_INVESTIGATOR
NSABP Foundation Inc
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
Kaiser Permanente-San Diego
San Diego, California, United States
Kaiser Permanente-Vallejo
Vallejo, California, United States
University of Florida
Gainesville, Florida, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States
UF Cancer Center at Orlando Health
Orlando, Florida, United States
Memorial University Medical Center
Savannah, Georgia, United States
St. Luke's Mountain States Tumor Institute - Boise
Boise, Idaho, United States
Kootenai Health Cancer Services
Post Falls, Idaho, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Medstar Franklin Square Medical Center, Weinberg Cancer Institute
Baltimore, Maryland, United States
Holy Cross Hospital
Silver Spring, Maryland, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
Cancer Research Consortium of West Michigan
Grand Rapids, Michigan, United States
CCOP, Kalamazoo, MI
Kalamazoo, Michigan, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Randolph Hospital
Asheboro, North Carolina, United States
Mission Hospitals
Asheville, North Carolina, United States
Carolinas Medical Center/Levine Cancer Center
Charlotte, North Carolina, United States
Presbyterian Hospital
Charlotte, North Carolina, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, United States
CCOP - Cone Health Cancer Center
Greensboro, North Carolina, United States
High Point Regional Hospital
High Point, North Carolina, United States
FirstHealth of the Carolinas-Moore Regional Hosiptal
Pinehurst, North Carolina, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, United States
CCOP Forsyth Memorial Hospital
Winston-Salem, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Sanford Medical Center
Fargo, North Dakota, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Allegheny General Hospital/Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Reading Hospital and Medical Center
West Reading, Pennsylvania, United States
Roper Hospital
Charleston, South Carolina, United States
Cancer Centers of the Carolinas (International)
Greenville, South Carolina, United States
CCOP - Sanford Research
Sioux Falls, South Dakota, United States
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, United States
Virginia Oncology Associates - Hampton
Hampton, Virginia, United States
MBCCOP, Virginia Commonwealth University
Richmond, Virginia, United States
CCOP, St. Vincent Hospital
Green Bay, Wisconsin, United States
CCOP, Marshfield Clinic
Marshfield, Wisconsin, United States
Aurora Health Care
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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NSABP MPR-1
Identifier Type: -
Identifier Source: org_study_id
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