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

July 23, 2014 updated by: Southwest Oncology Group

Pharmacogenomics of Oxidative Stress-Related Genes in Lymphoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

337

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients enrolled on S8516 S8736 S9125 S9240 consenting to banking

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Association of polymorphisms in oxidative stress-related genes with overall survival and/or progression-free survival
Time Frame: retrospectively
retrospectively
Association of polymorphisms in these genes with rate of grade 4-5 hematologic toxicity
Time Frame: retrospectively
retrospectively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Margaret M. Briehl, PhD, University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 25, 2009

First Submitted That Met QC Criteria

September 25, 2009

First Posted (Estimate)

September 28, 2009

Study Record Updates

Last Update Posted (Estimate)

July 24, 2014

Last Update Submitted That Met QC Criteria

July 23, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000643248
  • U10CA032102 (U.S. NIH Grant/Contract)
  • SWOG-S8516-S8736-S9125-S9240-S (Other Identifier: SWOG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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