Studying Genes in Samples From Patients With Limited or Advanced Diffuse Large B-Cell Lymphoma
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Purpose
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors find better ways to treat cancer.
PURPOSE: This research trial studies genes in samples from patients with limited and advanced diffuse large B-cell lymphoma.
| Condition | Intervention |
|---|---|
|
Lymphoma |
Genetic: RNA analysis Genetic: gene expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Official Title: | Determining the Cell of Origin and Prognostic Gene Signatures in SWOG Trials of Diffuse Large B-Cell Lymphoma |
- Proportion of GCB phenotype among limited-stage vs advanced-stage patients [ Designated as safety issue: No ]
- Differences in PFS between limited- and advanced-stage patients with the GCB and non-GCB phenotypes [ Designated as safety issue: No ]
- Association between GCB markers and OS [ Designated as safety issue: No ]
| Estimated Enrollment: | 220 |
| Study Start Date: | February 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- To determine the proportion of the cell of origin subtypes (germinal center B-cell-like [GCB] vs non-GCB) and expression levels of prognostic genes previously identified in diffuse large B-cell lymphoma (DLBCL) in patient biopsy samples from SWOG trials of limited- and advanced-stage DLBCL, and to assess the association between the results and progression-free survival (PFS).
- To assess the association between these marker results and overall survival (OS).
OUTLINE: Archived formalin-fixed paraffin-embedded tissue are analyzed for gene expression profile by quantitative nuclease protection assay (qNPA) and immunohistochemical analyses. Results are then compared with each patient's progression-free survival and overall survival.
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Diffuse large B-cell lymphoma - Initial diagnostic tissue block, or 4 unstained slides
Tissue from patients with limited-stage DLBCL enrolled on SWOG trials treated with cyclophosphamide, doxorubicin hydrochloride, prednisone, and vincristine sulfate (CHOP), and monoclonal anti-CD20 antibody backbone
- SWOG-S0014
- SWOG-S0313
Tissue from patients with advanced-stage DLBCL enrolled on SWOG trials treated with CHOP and monoclonal anti-CD20 antibody backbone
- SWOG-S9704
- SWOG-S0433
- SWOG-S0515
- SWOG-S0806
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Laurence H. Baker, Southwest Oncology Group - Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT01563861 History of Changes |
| Other Study ID Numbers: | CDR0000729157, S9704-S0014-S0313A |
| Study First Received: | March 23, 2012 |
| Last Updated: | March 23, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |
ClinicalTrials.gov processed this record on May 22, 2013