S9704-S0014-S0313A Studying Genes in Samples From Patients With Limited or Advanced Diffuse Large B-Cell Lymphoma

Sponsor

Southwest Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT01563861

Collaborator

National Cancer Institute (NCI) (NIH)

397

Enrollment

193.5

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Lymphoma	Genetic: RNA analysis Genetic: gene expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

397 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Determining the Cell of Origin and Prognostic Gene Signatures in SWOG Trials of Diffuse Large B-Cell Lymphoma

Actual Study Start Date :

Sep 15, 1997

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Oct 31, 2013

Outcome Measures

Primary Outcome Measures

Proportion of GCB phenotype among limited-stage vs advanced-stage patients [Retrospectively]
Differences in PFS between limited- and advanced-stage patients with the GCB and non-GCB phenotypes [Retrospectively]
Association between GCB markers and OS [Retrospectively]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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