Clinical trial NCT01793805: NSABP Patient Registry and Biospecimen Profiling Repository
Official title: NSABP Patient Registry and Biospecimen Profiling Repository
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: NSABP Foundation Inc
Sponsor class: NETWORK
First posted: 2013-02-18
Enrollment: 3232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Metastatic colorectal cancer patients.

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.

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 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.

Primary outcomes:
measure: To characterize common genetic/molecular profiles associated with colorectal cancer (CRC)
timeFrame: From start of study through study completion at approximately 6 months
Secondary outcomes:
measure: 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
timeFrame: From start of study through study completion at approximately 6 months
measure: To conduct further analysis of tumor samples for the discovery of new potential targets and mechanisms of drug resistance
timeFrame: From start of study through study completion at approximately 6 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: San Diego
country: United States
facility: Kaiser Permanente-San Diego
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente-Vallejo
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Baptist Cancer Institute - Jacksonville
state: Florida
city: Orlando
country: United States
facility: UF Cancer Center at Orlando Health
state: Florida
city: Savannah
country: United States
facility: Memorial University Medical Center
state: Georgia
city: Boise
country: United States
facility: St. Luke's Mountain States Tumor Institute - Boise
state: Idaho
city: Post Falls
country: United States
facility: Kootenai Health Cancer Services
state: Idaho
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: South Bend
country: United States
facility: CCOP - Northern Indiana CR Consortium
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Baltimore
country: United States
facility: Medstar Franklin Square Medical Center, Weinberg Cancer Institute
state: Maryland
city: Silver Spring
country: United States
facility: Holy Cross Hospital
state: Maryland
city: Ann Arbor
country: United States
facility: CCOP - Michigan Cancer Research Consortium
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer Research Consortium of West Michigan
state: Michigan
city: Kalamazoo
country: United States
facility: CCOP, Kalamazoo, MI
state: Michigan
city: Saint Louis Park
country: United States
facility: CCOP - Metro-Minnesota
state: Minnesota
city: Omaha
country: United States
facility: CCOP - Missouri Valley Cancer Consortium
state: Nebraska
city: Asheboro
country: United States
facility: Randolph Hospital
state: North Carolina
city: Asheville
country: United States
facility: Mission Hospitals
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center/Levine Cancer Center
state: North Carolina
city: Charlotte
country: United States
facility: Presbyterian Hospital
state: North Carolina
city: Goldsboro
country: United States
facility: Wayne Memorial Hospital
state: North Carolina
city: Greensboro
country: United States
facility: CCOP - Cone Health Cancer Center
state: North Carolina
city: High Point
country: United States
facility: High Point Regional Hospital
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth of the Carolinas-Moore Regional Hosiptal
state: North Carolina
city: Reidsville
country: United States
facility: Annie Penn Memorial Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: CCOP Forsyth Memorial Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Fargo
country: United States
facility: Sanford Medical Center
state: North Dakota
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital/Allegheny-Singer Research Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Hospital and Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Roper Hospital
state: South Carolina
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas (International)
state: South Carolina
city: Sioux Falls
country: United States
facility: CCOP - Sanford Research
state: South Dakota
city: Kingsport
country: United States
facility: Wellmont Holston Valley Hospital and Medical Center
state: Tennessee
city: Hampton
country: United States
facility: Virginia Oncology Associates - Hampton
state: Virginia
city: Richmond
country: United States
facility: MBCCOP, Virginia Commonwealth University
state: Virginia
city: Green Bay
country: United States
facility: CCOP, St. Vincent Hospital
state: Wisconsin
city: Marshfield
country: United States
facility: CCOP, Marshfield Clinic
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Health Care
state: Wisconsin
Study officials:
affiliation: NSABP Foundation Inc
name: Norman Wolmark, MD
role: PRINCIPAL_INVESTIGATOR
References: