Clinical trial NCT01563861: S9704-S0014-S0313A Studying Genes in Samples From Patients With Limited or Advanced Diffuse Large B-Cell Lymphoma
Official title: Determining the Cell of Origin and Prognostic Gene Signatures in SWOG Trials of Diffuse Large B-Cell Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: SWOG Cancer Research Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-03-27
Enrollment: 397
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients registering to S9704-S0014-S0313 consenting to banking

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.

Eligibility 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

Primary outcomes:
measure: Proportion of GCB phenotype among limited-stage vs advanced-stage patients
timeFrame: Retrospectively
measure: Differences in PFS between limited- and advanced-stage patients with the GCB and non-GCB phenotypes
timeFrame: Retrospectively
measure: Association between GCB markers and OS
timeFrame: Retrospectively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Arizona
name: Daniel O. Persky, MD
role: PRINCIPAL_INVESTIGATOR
References: