Completed

Genetic Changes in Diffuse Aggressive Non-Hodgkin's Lymphoma

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What is being collected

Genetic Data

+ genetic Data

+ genetic Data

Collected from today forward - Prospective
GeneticDNA Samples
Who is being recruted

DNA Virus Infections+17

+ Hemic and Lymphatic Diseases

+ Herpesviridae Infections

Over 18 Years
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: June 1999
See protocol details

Summary

Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: July 6, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00003863
Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: July 6, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

391 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DNA Virus InfectionsHemic and Lymphatic DiseasesHerpesviridae InfectionsImmune System DiseasesImmunoproliferative DisordersInfectionsLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeTumor Virus InfectionsVirus DiseasesLymphoma, B-CellEpstein-Barr Virus InfectionsBurkitt LymphomaLymphomaLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticLymphoma, Large B-Cell, DiffuseLymphoma, Mantle-Cell

Criteria

DISEASE CHARACTERISTICS: 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 69 locations

Northeast Alabama Regional Medical Center

Anniston, United StatesOpen Northeast Alabama Regional Medical Center in Google Maps

Rebecca and John Moores UCSD Cancer Center

La Jolla, United States

Naval Medical Center - San Diego

San Diego, United States

Veterans Affairs Medical Center - San Diego

San Diego, United States
Completed69 Study Centers