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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01563861
Enrollment
397
Registered
2012-03-27
Start date
1997-09-15
Completion date
2013-10-31
Last updated
2019-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

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

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.

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.

Interventions

GENETICRNA analysis
GENETICgene expression analysis
OTHERimmunohistochemistry staining method
OTHERlaboratory biomarker analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
SWOG Cancer Research Network
Lead SponsorNETWORK

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Proportion of GCB phenotype among limited-stage vs advanced-stage patientsRetrospectively
Differences in PFS between limited- and advanced-stage patients with the GCB and non-GCB phenotypesRetrospectively
Association between GCB markers and OSRetrospectively

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026