Diagnostic Study of Patients With Aggressive Non-Hodgkin's Lymphoma
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Lymphoma |
Genetic: comparative genomic hybridization Genetic: cytogenetic analysis Genetic: fluorescence in situ hybridization Genetic: gene rearrangement analysis |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Diagnostic |
| Official Title: | Genetic Changes in Diffuse Aggressive Non-Hodgkin's Lymphoma |
| Study Start Date: | June 1999 |
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.
PROJECTED ACCRUAL: A total of 391 patients will be accrued for this study within 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
- Adult
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Contacts and Locations
Show 69 Study Locations| Study Chair: | Raju S. K. Chaganti, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00003863 History of Changes |
| Other Study ID Numbers: | CDR0000067027, CALGB-9764 |
| Study First Received: | November 1, 1999 |
| Last Updated: | April 11, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I adult diffuse small cleaved cell lymphoma stage I adult diffuse mixed cell lymphoma stage I adult diffuse large cell lymphoma stage I adult immunoblastic large cell lymphoma stage I adult Burkitt lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse large cell lymphoma stage III adult immunoblastic large cell lymphoma stage III adult Burkitt lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult Burkitt lymphoma |
recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult Burkitt lymphoma stage I mantle cell lymphoma contiguous stage II adult diffuse small cleaved cell lymphoma contiguous stage II mantle cell lymphoma contiguous stage II adult diffuse mixed cell lymphoma contiguous stage II adult immunoblastic large cell lymphoma contiguous stage II adult diffuse large cell lymphoma contiguous stage II adult Burkitt lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II mantle cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Immunoblastic Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013