S8516-S8736-S9125-S9240 Research Study of Genes in Tissue Samples From Patients With B-cell Non-Hodgkin Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00985699
First received: September 25, 2009
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at genes in tissue samples from patients with B-cell non-Hodgkin lymphoma.


Condition Intervention
Lymphoma
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Other: pharmacogenomic studies

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Pharmacogenomics of Oxidative Stress-Related Genes in Lymphoma

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Association of polymorphisms in oxidative stress-related genes with overall survival and/or progression-free survival [ Time Frame: retrospectively ] [ Designated as safety issue: No ]
  • Association of polymorphisms in these genes with rate of grade 4-5 hematologic toxicity [ Time Frame: retrospectively ] [ Designated as safety issue: No ]

Enrollment: 337
Study Start Date: April 2009
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To determine if toxicity following treatment for lymphoma varies according to genetic polymorphisms in oxidative stress-related genes (i.e., SOD2, CAT, GPX1, GSTM1, and GSTP1).
  • To assess whether these genetic polymorphisms are associated with progression-free survival and/or overall survival in these patients treated for lymphoma.

OUTLINE: Previously collected samples are used for biomarker analysis.

  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 enrolled on S8516 S8736 S9125 S9240 consenting to banking

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of aggressive B-cell non-Hodgkin lymphoma

    • Previously treated with curative intent using anthracycline-based therapies
  • Previously collected paraffin-embedded diagnostic tissues from clinical trials that were collected as part of SWOG treatment protocols (S8516, S8736, S9125, S9240, and S9349) available

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: NCT00985699

Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Margaret M. Briehl, PhD University of Arizona
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00985699     History of Changes
Other Study ID Numbers: CDR0000643248, SWOG-S8516-S8736-S9125-S9240-S, U10CA032102
Study First Received: September 25, 2009
Last Updated: July 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
non-Hodgkin lymphoma
cutaneous B-cell non-Hodgkin lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on October 02, 2014