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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer

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 Type: Observational
• Enrollment (Actual): 3232

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Metastatic colorectal cancer patients.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Metastatic Colorectal Cancer Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To characterize common genetic/molecular profiles associated with colorectal cancer (CRC)	This is a living registry with no end date provided continued funding.	From start of study through study completion at approximately 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: NSABP Foundation Inc

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: February 11, 2013
• First Submitted That Met QC Criteria: February 14, 2013
• First Posted (Estimate): February 18, 2013

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: NSABP MPR-1