Diagnostic Study of Patients With Aggressive Non-Hodgkin's Lymphoma
NCT ID: NCT00003863
Last Updated: 2016-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
391 participants
OBSERVATIONAL
1999-06-30
2005-05-31
Brief Summary
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PURPOSE: Diagnostic study to determine the genetic markers in patients who have aggressive non-Hodgkin's lymphoma.
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Detailed Description
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* Estimate the proportions of patients with diffuse aggressive non-Hodgkin's lymphoma who have rearrangements affecting the MYC, BCL2, and BCL6 genes (determined by fluorescent in situ hybridization), overtly amplified chromosomal regions, and nonrandom copy number changes of chromosomal regions (determined by comparative genomic hybridization).
* Investigate the prognostic importance of these genetic markers by studying their relationships with clinical outcomes (e.g., response to therapy, failure-free survival, and overall survival) in these patients.
* Investigate the interrelationships among these genetic and biological markers and their relationships with clinical features of the disease, such as disease site (nodal vs extranodal) and stage, in these patients.
OUTLINE: This is a multicenter study.
Tissue samples are obtained before treatment and at the time of documentation of refractory disease in patients who do not achieve complete remission after induction therapy or at the time of first relapse in patients who achieve a complete remission.
Samples are examined for rearrangements in the MYC, BCL2, BCL6, and IGH genes using fluorescent in situ hybridization. DNA is examined by comparative genomic hybridization, which allows cytogenetic detection of losses and gains of chromosomal regions in tumor cells.
Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Group 1
Tissue samples are obtained before treatment and at the time of documentation of refractory disease in patients who do not achieve complete remission after induction therapy or at the time of first relapse in patients who achieve a complete remission.
Samples are examined for rearrangements in the MYC, BCL2, BCL6, and IGH genes using fluorescent in situ hybridization. DNA is examined by comparative genomic hybridization, which allows cytogenetic detection of losses and gains of chromosomal regions in tumor cells.
Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.
comparative genomic hybridization
cytogenetic analysis
fluorescence in situ hybridization
gene rearrangement analysis
Interventions
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comparative genomic hybridization
cytogenetic analysis
fluorescence in situ hybridization
gene rearrangement analysis
Eligibility Criteria
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Inclusion Criteria
* Histologically proven aggressive non-Hodgkin's lymphoma and registered to front-line CALGB protocols (e.g, CLB-59903, 59909, 10002, and 50103)
* Diffuse small cleaved cell lymphoma
* Diffuse mixed small and large cell lymphoma
* Diffuse large cell lymphoma
* Diffuse large cell immunoblastic lymphoma
* Small noncleaved cell lymphoma
* Mantle cell lymphoma OR
* Previously entered on similar curative CALGB protocols (CLB-8852, CLB-8854, and CLB-9351) with blocks or unstained slides of initial diagnosis available
PATIENT CHARACTERISTICS:
Age:
* 18 years and older
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Raju Chaganti, PhD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Locations
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Northeast Alabama Regional Medical Center
Anniston, Alabama, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Naval Medical Center - San Diego
San Diego, California, United States
Veterans Affairs Medical Center - San Diego
San Diego, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Lombardi Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Veterans Affairs Medical Center - Chicago Westside Hospital
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
West Suburban Center for Cancer Care
River Forest, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Baptist Hospital East - Louisville
Louisville, Kentucky, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph, Michigan, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, United States
New Hampshire Oncology-Hematology, PA - Hooksett
Hooksett, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cancer Institute of New Jersey at the Cooper University Hospital
Camden, New Jersey, United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
East Syracuse, New York, United States
Elmhurst Hospital Center
Elmhurst, New York, United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
NorthEast Oncology Associates - Concord
Concord, North Carolina, United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Cape Fear Valley Medical Center
Fayetteville, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States
Lenoir Memorial Cancer Center
Kinston, North Carolina, United States
Comprehensive Cancer Center at Moore Regional Hospital
Pinehurst, North Carolina, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Miriam Hospital at Lifespan
Providence, Rhode Island, United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, United States
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States
Cancer Care Center at Martha Jefferson Hospital
Charlottesville, Virginia, United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
Roanoke, Virginia, United States
St. Mary's Medical Center
Huntington, West Virginia, United States
Countries
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Other Identifiers
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CALGB-9764
Identifier Type: -
Identifier Source: secondary_id
CDR0000067027
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-9764
Identifier Type: -
Identifier Source: org_study_id
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