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NSABP Patient Registry and Biospecimen Profiling Repository

Sponsor
NSABP Foundation Inc (Other)
Overall Status
Completed
CT.gov ID
NCT01793805
Collaborator
(none)
3,232
Enrollment
46
Locations
108.9
Duration (Months)
70.3
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    3232 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    NSABP Patient Registry and Biospecimen Profiling Repository
    Study Start Date :
    Feb 1, 2013
    Actual Primary Completion Date :
    Mar 1, 2022
    Actual Study Completion Date :
    Mar 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Metastatic Colorectal Cancer Patients

    Outcome Measures

    Primary Outcome Measures

    1. To characterize common genetic/molecular profiles associated with colorectal cancer (CRC) [From start of study through study completion at approximately 6 months]

      This is a living registry with no end date provided continued funding.

    Secondary Outcome Measures

    1. 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 [From start of study through study completion at approximately 6 months]

    2. To conduct further analysis of tumor samples for the discovery of new potential targets and mechanisms of drug resistance [From start of study through study completion at approximately 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 City of Hope Comprehensive Cancer Center Duarte California United States 91010
    2 Kaiser Permanente-San Diego San Diego California United States 92120
    3 Kaiser Permanente-Vallejo Vallejo California United States 94589
    4 University of Florida Gainesville Florida United States 32610
    5 Baptist Cancer Institute - Jacksonville Jacksonville Florida United States 32207
    6 UF Cancer Center at Orlando Health Orlando Florida United States 32806
    7 Memorial University Medical Center Savannah Georgia United States 31404
    8 St. Luke's Mountain States Tumor Institute - Boise Boise Idaho United States 83712
    9 Kootenai Health Cancer Services Post Falls Idaho United States 83854
    10 Decatur Memorial Hospital Decatur Illinois United States 62526
    11 CCOP - Northern Indiana CR Consortium South Bend Indiana United States 46601
    12 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    13 Medstar Franklin Square Medical Center, Weinberg Cancer Institute Baltimore Maryland United States 21237
    14 Holy Cross Hospital Silver Spring Maryland United States 20910
    15 CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan United States 48106
    16 Henry Ford Health System Detroit Michigan United States 48202
    17 Michigan State University East Lansing Michigan United States 48824
    18 Cancer Research Consortium of West Michigan Grand Rapids Michigan United States 49503
    19 CCOP, Kalamazoo, MI Kalamazoo Michigan United States 49007
    20 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
    21 CCOP - Missouri Valley Cancer Consortium Omaha Nebraska United States 68131
    22 Randolph Hospital Asheboro North Carolina United States 27203
    23 Mission Hospitals Asheville North Carolina United States 28801
    24 Carolinas Medical Center/Levine Cancer Center Charlotte North Carolina United States 28203
    25 Presbyterian Hospital Charlotte North Carolina United States 28233
    26 Wayne Memorial Hospital Goldsboro North Carolina United States 27534
    27 CCOP - Cone Health Cancer Center Greensboro North Carolina United States 27403
    28 High Point Regional Hospital High Point North Carolina United States 27261
    29 FirstHealth of the Carolinas-Moore Regional Hosiptal Pinehurst North Carolina United States 28374
    30 Annie Penn Memorial Hospital Reidsville North Carolina United States 27320
    31 CCOP Forsyth Memorial Hospital Winston-Salem North Carolina United States 27103
    32 Wake Forest University School of Medicine Winston-Salem North Carolina United States 27157
    33 Sanford Medical Center Fargo North Dakota United States 58122
    34 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
    35 Allegheny General Hospital/Allegheny-Singer Research Institute Pittsburgh Pennsylvania United States 15212
    36 University of Pittsburgh Pittsburgh Pennsylvania United States 15213
    37 Reading Hospital and Medical Center West Reading Pennsylvania United States 19611
    38 Roper Hospital Charleston South Carolina United States 29401
    39 Cancer Centers of the Carolinas (International) Greenville South Carolina United States 29615
    40 CCOP - Sanford Research Sioux Falls South Dakota United States 57104
    41 Wellmont Holston Valley Hospital and Medical Center Kingsport Tennessee United States 37660
    42 Virginia Oncology Associates - Hampton Hampton Virginia United States 23666
    43 MBCCOP, Virginia Commonwealth University Richmond Virginia United States 23298
    44 CCOP, St. Vincent Hospital Green Bay Wisconsin United States 54301
    45 CCOP, Marshfield Clinic Marshfield Wisconsin United States 54449
    46 Aurora Health Care Milwaukee Wisconsin United States 53215

    Sponsors and Collaborators

    • NSABP Foundation Inc

    Investigators

    • Principal Investigator: Norman Wolmark, MD, NSABP Foundation Inc

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NSABP Foundation Inc
    ClinicalTrials.gov Identifier:
    NCT01793805
    Other Study ID Numbers:
    • NSABP MPR-1
    First Posted:
    Feb 18, 2013
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Additional relevant MeSH terms:
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Mar 31, 2022