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NCT00985699 Clinical Trial

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

Lymphoma Clinical Trial

Official title:
Pharmacogenomics of Oxidative Stress-Related Genes in Lymphoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00985699
Other study ID # CDR0000643248
Secondary ID SWOG-S8516-S8736
Status Completed
Phase N/A
First received September 25, 2009
Last updated July 23, 2014
Start date April 2009
Est. completion date June 2014

Study information
Verified date July 2014
Source Southwest Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 337
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Genetic:
• polymorphism analysis

Other:
• laboratory biomarker analysis

• pharmacogenomic studies

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Southwest Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Association of polymorphisms in oxidative stress-related genes with overall survival and/or progression-free survival retrospectively No
Primary Association of polymorphisms in these genes with rate of grade 4-5 hematologic toxicity retrospectively No
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