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Completed

NCT Number: NCT00900484

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Registered on an active Southwest Oncology Group (SWOG)-coordinated treatment protocol for previously untreated non-Hodgkin's lymphoma
  • Adequate pretreatment diagnostic tissue available meeting the following requirements:
  • Fresh snap-frozen pretreatment diagnostic biopsy from any site (initial biopsy or rebiopsy)
  • 1 Hematoxylin and Eosin stained slide
  • 1 paraffin block and surgery pathology report

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Treatment and study plan

biologic sample preservation procedure

Other

immunohistochemistry staining method

Other

laboratory biomarker analysis

Other

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

SWOG Cancer Research Network

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Central Lymphoma Repository Tissue Procurement Protocol

Important dates

Study start
1989
Primary completion
2011
Study completion
2011
First posted
May 12, 2009
Registry last updated
May 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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