NCT Number: NCT00003863
Diagnostic Study of Patients With Aggressive Non-Hodgkin's Lymphoma
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Northeast Alabama Regional Medical Center, Anniston, Alabama, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
cytogenetic analysis
Geneticfluorescence in situ hybridization
Geneticgene rearrangement analysis
GeneticPrimary outcomes
-
response to therapy
Time frame: Up to 5 years
Secondary outcomes
-
failure-free survival
Time frame: Up to 5 years
-
overall survival
Time frame: Up to 5 years
Sponsors and collaborators
Lead sponsor
Alliance for Clinical Trials in Oncology
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Genetic Changes in Diffuse Aggressive Non-Hodgkin's Lymphoma
Important dates
- Study start
- 1999
- Primary completion
- 2005
- Study completion
- 2005
- First posted
- Jan 27, 2003
- Registry last updated
- Jul 6, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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