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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00900484
First received: May 9, 2009
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

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 Intervention
Lymphoma
Other: biologic sample preservation procedure
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Central Lymphoma Repository Tissue Procurement Protocol

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    feasibility of collecting specimens


Biospecimen Retention:   Samples With DNA

Tissue collected for patients consenting to banking on SWOG lymphoma protocols


Enrollment: 458
Study Start Date: February 1989
Study Completion Date: October 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients consenting to SWOG 8819 banking protocol

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900484

  Show 191 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Lisa Rimsza, MD University of Arizona
  More Information

Additional Information:
Publications:
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00900484     History of Changes
Other Study ID Numbers: CDR0000078649, SWOG-8819, U10CA032102
Study First Received: May 9, 2009
Last Updated: May 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
stage I adult diffuse large cell lymphoma
stage I adult diffuse mixed cell lymphoma
stage I adult diffuse small cleaved cell lymphoma
stage II adult diffuse large cell lymphoma
stage II adult diffuse mixed cell lymphoma
stage II adult diffuse small cleaved cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage I grade 3 follicular lymphoma
stage II grade 3 follicular lymphoma
stage III grade 3 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage I adult immunoblastic large cell lymphoma
stage II adult immunoblastic large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage I adult lymphoblastic lymphoma
stage II adult lymphoblastic lymphoma
stage III adult lymphoblastic lymphoma
stage IV adult lymphoblastic lymphoma
stage I adult Burkitt lymphoma
stage II adult Burkitt lymphoma
stage III adult Burkitt lymphoma
stage IV adult Burkitt lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Immunoblastic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014