Biomarkers in Patients With Stage III or Stage IV Follicular Lymphoma Treated on Clinical Trial E-1496
|ClinicalTrials.gov Identifier: NCT00898963|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 19, 2017
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|
|Lymphoma||Genetic: gene expression analysis Genetic: microarray analysis Genetic: polymorphism analysis Other: diagnostic laboratory biomarker analysis Other: immunohistochemistry staining method Other: immunologic technique|
- 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 Type :||Observational|
|Actual Enrollment :||175 participants|
|Official Title:||Identification of Biomarkers in Follicular Lymphoma|
|Actual Study Start Date :||April 18, 2007|
|Primary Completion Date :||December 21, 2011|
|Study Completion Date :||December 21, 2011|
- Correlation of gene expression profiles with progression-free survival (PFS) [ Time Frame: 1 month ]
- Prediction of PFS by immunoglobulin Fc-gamma receptor polymorphisms as assessed by immunohistochemistry [ Time Frame: 1 month ]
- Assessment of significance of microenvironment by constructing tissue microarrays and immunostaining with relevant biomarkers [ Time Frame: 1 month ]
- Correlation of relevant biomarkers with clinical features, response, and PFS [ Time Frame: 1 month ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898963
|Study Chair:||Randall D. Gascoyne, MD||British Columbia Cancer Agency|