NSABP Patient Registry and Biospecimen Profiling Repository

Colorectal Cancer Clinical Trial

Official title:

NSABP Patient Registry and Biospecimen Profiling Repository

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01793805
• Other study ID #: NSABP MPR-1
• Status: Completed
• Start date: February 2013
• Est. completion date: March 2022

Study information

• Verified date: March 2022
• Source: NSABP Foundation Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3232
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Randolph Hospital	Asheboro	North Carolina
United States	Mission Hospitals	Asheville	North Carolina
United States	Medstar Franklin Square Medical Center, Weinberg Cancer Institute	Baltimore	Maryland
United States	St. Luke's Mountain States Tumor Institute - Boise	Boise	Idaho
United States	Roper Hospital	Charleston	South Carolina
United States	Carolinas Medical Center/Levine Cancer Center	Charlotte	North Carolina
United States	Presbyterian Hospital	Charlotte	North Carolina
United States	Decatur Memorial Hospital	Decatur	Illinois
United States	Henry Ford Health System	Detroit	Michigan
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Michigan State University	East Lansing	Michigan
United States	Sanford Medical Center	Fargo	North Dakota
United States	University of Florida	Gainesville	Florida
United States	Wayne Memorial Hospital	Goldsboro	North Carolina
United States	Cancer Research Consortium of West Michigan	Grand Rapids	Michigan
United States	CCOP, St. Vincent Hospital	Green Bay	Wisconsin
United States	CCOP - Cone Health Cancer Center	Greensboro	North Carolina
United States	Cancer Centers of the Carolinas (International)	Greenville	South Carolina
United States	Virginia Oncology Associates - Hampton	Hampton	Virginia
United States	High Point Regional Hospital	High Point	North Carolina
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Baptist Cancer Institute - Jacksonville	Jacksonville	Florida
United States	CCOP, Kalamazoo, MI	Kalamazoo	Michigan
United States	Wellmont Holston Valley Hospital and Medical Center	Kingsport	Tennessee
United States	CCOP, Marshfield Clinic	Marshfield	Wisconsin
United States	Aurora Health Care	Milwaukee	Wisconsin
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	UF Cancer Center at Orlando Health	Orlando	Florida
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	FirstHealth of the Carolinas-Moore Regional Hosiptal	Pinehurst	North Carolina
United States	Allegheny General Hospital/Allegheny-Singer Research Institute	Pittsburgh	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Kootenai Health Cancer Services	Post Falls	Idaho
United States	Annie Penn Memorial Hospital	Reidsville	North Carolina
United States	MBCCOP, Virginia Commonwealth University	Richmond	Virginia
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Kaiser Permanente-San Diego	San Diego	California
United States	Memorial University Medical Center	Savannah	Georgia
United States	Holy Cross Hospital	Silver Spring	Maryland
United States	CCOP - Sanford Research	Sioux Falls	South Dakota
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Kaiser Permanente-Vallejo	Vallejo	California
United States	Reading Hospital and Medical Center	West Reading	Pennsylvania
United States	CCOP Forsyth Memorial Hospital	Winston-Salem	North Carolina
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
NSABP Foundation Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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