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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563861
• Other study ID #: CDR0000729157
• Secondary ID: S9704-S0014-S031
• Status: Completed
• Start date: September 15, 1997
• Est. completion date: October 31, 2013

Study information

• Verified date: December 2019
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: October 31, 2013
• Est. primary completion date: June 1, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Genetic:
• RNA analysis

• gene expression analysis

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of GCB phenotype among limited-stage vs advanced-stage patients		Retrospectively
Primary	Differences in PFS between limited- and advanced-stage patients with the GCB and non-GCB phenotypes		Retrospectively
Primary	Association between GCB markers and OS		Retrospectively