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Clinical Trials/NCT00003863
NCT00003863CompletedNot Applicable

Genetic Changes in Diffuse Aggressive Non-Hodgkin's Lymphoma

Alliance for Clinical Trials in Oncology69 sites in 1 country391 target enrollmentStarted: June 1999Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
391
Locations
69
Primary Endpoint
response to therapy

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

response to therapy

Time Frame: Up to 5 years

Secondary Outcomes

  • failure-free survival(Up to 5 years)
  • overall survival(Up to 5 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (69)

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