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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Conditions
Age range
16 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Alaska Regional Hospital Cancer Center, Anchorage, Alaska, United States
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
immunohistochemistry staining method
Otherlaboratory biomarker analysis
OtherPrimary outcomes
-
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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