NSABP Patient Registry and Biospecimen Profiling Repository



Status:Recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2013
End Date:June 2016
Contact:Diana Gosik, RN, BS
Email:diana.gosik@nsabp.org
Phone:412-339-5333

Use our guide to learn which trials are right for you!

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.

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.

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.
We found this trial at
46
sites
Green Bay, Wisconsin 54301
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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Duarte, CA
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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Pittsburgh, PA
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5301 East Huron River Drive
Ann Arbor, Michigan 48106
1.877.590.5995
CCOP - Michigan Cancer Research Consortium The Community Clinical Oncology Program (CCOP) is a comprehensive...
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Ann Arbor, MI
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364 White Oak St
Asheboro, North Carolina 27203
(336) 625-5151
Randolph Hospital Since 1932, Randolph Hospital has been fortunate to employ dedicated and loyal personnel...
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Asheboro, NC
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509 Biltmore Ave
Asheville, North Carolina 28801
(828) 213-1111
Mission Hospitals Mission Hospital, the flagship hospital of Mission Health, has been committed to improving...
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Asheville, NC
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Baltimore, MD
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Boise, ID
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Charleston, South Carolina 29401
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Charleston, SC
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Charlotte, North Carolina 28203
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Charlotte, NC
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200 Hawthorne Ln
Charlotte, North Carolina 28204
(704) 384-4000
Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming a new era in...
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Charlotte, NC
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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Decatur, IL
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Detroit, Michigan 48202
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Detroit, MI
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East Lansing, Michigan 48824
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East Lansing, MI
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Fargo, North Dakota 58122
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Fargo, ND
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2700 Wayne Memorial Dr
Goldsboro, North Carolina 27534
(919) 736-1110
Wayne Memorial Hospital Wayne Memorial Hospital, an affiliate of Wayne Health Corporation, is home to...
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Goldsboro, NC
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Grand Rapids, Michigan 49503
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Grand Rapids, MI
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Greensboro, North Carolina 27403
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Greenville, South Carolina 29615
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Greenville, SC
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Hampton, Virginia 23666
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Hampton, VA
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High Point, North Carolina 27261
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High Point, NC
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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800 Prudential Drive
Jacksonville, Florida 32207
904.202.2000
Baptist Cancer Institute - Jacksonville For more than 20 years, health care consumers have named...
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Jacksonville, FL
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Kalamazoo, Michigan 49007
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Kalamazoo, MI
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Kingsport, TN
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Marshfield, Wisconsin 54449
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Marshfield, WI
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Milwaukie, Wisconsin 53215
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Milwaukie, WI
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Omaha, NE
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Orlando, Florida 32806
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Orlando, FL
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Philadelphia, PA
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Pinehurst, NC
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Pittsburgh, PA
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Post Falls, Idaho 83854
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Post Falls, ID
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Reidsville, North Carolina 27320
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Reidsville, NC
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Richmond, Virginia 23298
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Richmond, VA
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Saint Louis Park, Minnesota 55416
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Saint Louis Park, MN
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San Diego, California 92120
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San Diego, CA
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Savannah, Georgia 31404
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Savannah, GA
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Silver Spring, Maryland 20910
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Silver Spring, MD
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Souix Falls, South Dakota 57104
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Souix Falls, SD
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South Bend, Indiana 46601
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South Bend, IN
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Vallejo, California 94589
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Vallejo, CA
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West Reading, Pennsylvania 19612
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Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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Winston-Salem, North Carolina 26157
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