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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00900484
First Posted: May 12, 2009
Last Update Posted: May 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
  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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900484


  Show 191 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Lisa Rimsza, MD University of Arizona
  More Information

Publications:
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00900484     History of Changes
Other Study ID Numbers: CDR0000078649
SWOG-8819 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: May 20, 2013
Last Verified: May 2013

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
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases