Biomarkers in Patients With Stage III or Stage IV Follicular Lymphoma Treated on Clinical Trial E-1496

Sponsor

ECOG-ACRIN Cancer Research Group (Other)

Overall Status

Completed

CT.gov ID

NCT00898963

Collaborator

National Cancer Institute (NCI) (NIH)

175

Enrollment

45.8

Actual Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Studying samples of 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 predict how patients respond to treatment.

PURPOSE: This laboratory study is looking at biomarkers in patients with stage III or stage IV follicular lymphoma treated on clinical trial E-1496.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Genetic: gene expression analysis Genetic: microarray analysis Genetic: polymorphism analysis Other: diagnostic laboratory biomarker analysis Other: immunohistochemistry staining method Other: immunologic technique

Detailed Description

OBJECTIVES:

Correlate gene expression profiles with progression-free survival (PFS) of patients with stage III or IV follicular lymphoma treated with cyclophosphamide, vincristine, and prednisone with or without rituximab on clinical trial E-1496.
Determine if immunoglobulin Fc-gamma receptor polymorphisms are predictive of PFS in these patients.
Assess the significance of the microenvironment by constructing tissue microarrays of follicular lymphoma and immunostaining with relevant biomarkers.
Correlate relevant biomarkers with clinical features, response, and PFS.

OUTLINE: This is a multicenter study.

Tissue samples are analyzed by gene expression profiling, microarrays to predict gene expression, immunohistochemistry, and immunoglobulin Fc-gamma receptor polymorphism analysis for biological markers.

PROJECTED ACCRUAL: A total of 175 samples will be accrued for this study.

Study Design

Study Type:

Observational

Actual Enrollment :

175 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Identification of Biomarkers in Follicular Lymphoma

Actual Study Start Date :

Apr 18, 2007

Actual Primary Completion Date :

Feb 11, 2011

Actual Study Completion Date :

Feb 11, 2011

Outcome Measures

Primary Outcome Measures

Correlation of gene expression profiles with progression-free survival (PFS) [1 month]
Prediction of PFS by immunoglobulin Fc-gamma receptor polymorphisms as assessed by immunohistochemistry [1 month]
Assessment of significance of microenvironment by constructing tissue microarrays and immunostaining with relevant biomarkers [1 month]
Correlation of relevant biomarkers with clinical features, response, and PFS [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Diagnosis of follicular lymphoma
Stage III or IV disease
Received cyclophosphamide, vincristine, and prednisone with or without rituximab on clinical trial E-1496