Diagnostic Study of Patients With Aggressive Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Interventions
- Genetic: comparative genomic hybridizationGenetic: cytogenetic analysisGenetic: fluorescence in situ hybridizationGenetic: gene rearrangement analysis
- Registration Number
- NCT00003863
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Determination of genetic markers for aggressive non-Hodgkin's lymphoma may help identify patients with this disease and help predict the outcome of treatment.
PURPOSE: Diagnostic study to determine the genetic markers in patients who have aggressive non-Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 391
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 comparative genomic hybridization 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. Group 1 gene rearrangement analysis 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. Group 1 cytogenetic analysis 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. Group 1 fluorescence in situ hybridization 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.
- Primary Outcome Measures
Name Time Method response to therapy Up to 5 years
- Secondary Outcome Measures
Name Time Method failure-free survival Up to 5 years overall survival Up to 5 years
Trial Locations
- Locations (69)
Memorial Cancer Institute at Memorial Regional Hospital
🇺🇸Hollywood, 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
Fort Wayne Medical Oncology and Hematology, Incorporated
🇺🇸Fort Wayne, Indiana, United States
UMASS Memorial Cancer Center - University Campus
🇺🇸Worcester, Massachusetts, 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 - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸East Syracuse, New York, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
North Shore University Hospital
🇺🇸Manhasset, 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
Lenoir Memorial Cancer Center
🇺🇸Kinston, North Carolina, United States
Comprehensive Cancer Center at Moore Regional Hospital
🇺🇸Pinehurst, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
🇺🇸Columbus, Ohio, United States
Veterans Affairs Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Vermont Cancer Center at University of Vermont
🇺🇸Burlington, Vermont, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Northeast Alabama Regional Medical Center
🇺🇸Anniston, Alabama, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Lombardi Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
West Suburban Center for Cancer Care
🇺🇸River Forest, Illinois, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Veterans Affairs Medical Center - Washington, DC
🇺🇸Washington, District of Columbia, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Queens Cancer Center of Queens Hospital
🇺🇸Jamaica, New York, United States
Veterans Affairs Medical Center - Buffalo
🇺🇸Buffalo, New York, United States
New Hampshire Oncology-Hematology, PA - Hooksett
🇺🇸Hooksett, New Hampshire, United States
Cancer Institute of New Jersey at the Cooper University Hospital
🇺🇸Camden, New Jersey, United States
New York Weill Cornell Cancer Center at Cornell University
🇺🇸New York, New York, United States
Elmhurst Hospital Center
🇺🇸Elmhurst, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
NorthEast Oncology Associates - Concord
🇺🇸Concord, North Carolina, United States
Miriam Hospital at Lifespan
🇺🇸Providence, Rhode Island, United States
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
🇺🇸Roanoke, Virginia, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Goldsboro, North Carolina, United States
Cape Fear Valley Medical Center
🇺🇸Fayetteville, North Carolina, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, 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
St. Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Las Vegas
🇺🇸Las Vegas, Nevada, 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 - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Durham
🇺🇸Durham, North Carolina, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Baptist Hospital East - Louisville
🇺🇸Louisville, Kentucky, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States