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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01563861
First received: March 23, 2012
Last updated: May 23, 2014
Last verified: May 2014
  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
Study Design: Time Perspective: Retrospective
Official Title: Determining the Cell of Origin and Prognostic Gene Signatures in SWOG Trials of Diffuse Large B-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Proportion of GCB phenotype among limited-stage vs advanced-stage patients [ Time Frame: Retrospectively ] [ Designated as safety issue: No ]
  • Differences in PFS between limited- and advanced-stage patients with the GCB and non-GCB phenotypes [ Time Frame: Retrospectively ] [ Designated as safety issue: No ]
  • Association between GCB markers and OS [ Time Frame: Retrospectively ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: February 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients registering to S9704-S0014-S0313 consenting to banking

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563861

Sponsors and Collaborators
Southwest Oncology Group
Investigators
Principal Investigator: Daniel O. Persky, MD University of Arizona
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01563861     History of Changes
Other Study ID Numbers: CDR0000729157, S9704-S0014-S0313A, U10CA032102
Study First Received: March 23, 2012
Last Updated: May 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014