NCT00003863

Diagnostic Study of Patients With Aggressive Non-Hodgkin's Lymphoma

Genetic Changes in Diffuse Aggressive Non-Hodgkin's Lymphoma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 391 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
GENETIC	comparative genomic hybridization
GENETIC	cytogenetic analysis
GENETIC	fluorescence in situ hybridization
GENETIC	gene rearrangement analysis

Timeline

• Start date: 1999-06-01
• Primary completion: 2005-05-01
• Completion: 2005-05-01
• First posted: 2003-01-27
• Last updated: 2016-07-06

Locations

69 sites across 1 country: United States