NCT00900484

SWOG-8819 Collecting, Analyzing, and Storing Tissue Samples From Patients With Non-Hodgkin's Lymphoma

Central Lymphoma Repository Tissue Procurement Protocol

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 458 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
OTHER	biologic sample preservation procedure
OTHER	immunohistochemistry staining method
OTHER	laboratory biomarker analysis

Timeline

• Start date: 1989-02-01
• Primary completion: 2011-07-01
• Completion: 2011-10-01
• First posted: 2009-05-12
• Last updated: 2013-05-20

Locations

191 sites across 1 country: United States