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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01563861
First received: March 23, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  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
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 National Cancer Institute (NCI):

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

Estimated Enrollment: 220
Study Start Date: February 2012
Estimated 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:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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: Laurence H. Baker, Southwest Oncology Group - Group Chair's Office
ClinicalTrials.gov Identifier: NCT01563861     History of Changes
Other Study ID Numbers: CDR0000729157, S9704-S0014-S0313A
Study First Received: March 23, 2012
Last Updated: March 23, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on April 17, 2014