SWOG-8819 Collecting, Analyzing, and Storing Tissue Samples From Patients With Non-Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00900484|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 20, 2013
RATIONALE: Collecting and storing samples of tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. It may also help doctors learn how patients respond to treatment.
PURPOSE: This laboratory study is collecting, analyzing, and storing tissue samples from patients with non-Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment|
|Lymphoma||Other: biologic sample preservation procedure Other: immunohistochemistry staining method Other: laboratory biomarker analysis|
- Establish a central lymphoma tissue repository of fresh snap-frozen tissue from patients with previously untreated non-Hodgkin's lymphoma (NHL).
- Determine a standard set of procedures for routine acquisition, banking, and study of these tissue samples.
- Correlate presently activated phenotyping studies and future projected molecular studies of the DNA and RNA status of these tissue samples with clinical results.
- Correlate pretreatment phenotype or genotype of tissue samples from patients with intermediate- or high-grade NHL with patient outcome, in terms of complete response rate, time to progression, and survival.
- Correlate the lymphoma lineage (T-cell vs B-cell), loss of class II human histocompatibility antigen status (HLA-DR-positive vs HLA-DR-negative), proliferative index (as measured by Ki-67), and B- or T-cell antigen aberrancy (e.g., lack of Pan B or T antigen expression) with outcome in patients with intermediate- or high-grade NHL.
OUTLINE: Patients are treated on the SWOG study on which they are enrolled.
Tissue samples obtained before treatment began are banked in a tissue repository.
Samples from patients with intermediate- or high-grade non-Hodgkin's lymphoma are analyzed by three-stage immunohistochemistry using monoclonal antibodies to B-cell antigens, T-cell antigens, immunoglobulins, CALLA, HLA-DR, anti-interleukin-2 receptor, and Ki-67 (for the proliferative index). Phenotype (immune marker status, proliferation status, and activation status) is correlated with response to treatment, relapse, and overall survival.
PROJECTED ACCRUAL: Approximately 495 patients will be accrued for this study.
|Study Type :||Observational|
|Actual Enrollment :||458 participants|
|Official Title:||Central Lymphoma Repository Tissue Procurement Protocol|
|Study Start Date :||February 1989|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||October 2011|
- Establishment of a central lymphoma tissue repository of fresh snap-frozen tissue from patients with previously untreated non-Hodgkin's lymphoma (NHL) [ Time Frame: July 2011 ]feasibility of collecting specimens
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900484
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|Study Chair:||Lisa Rimsza, MD||University of Arizona|