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S8809-S9800-S9911TM- Biological Markers in Patients With Follicular Lymphoma Treated on Clinical Trial SWOG-8809, SWOG-9800, or SWOG-9911

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00896922
First Posted: May 12, 2009
Last Update Posted: February 28, 2017
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: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients respond to treatment.

PURPOSE: This laboratory study is examining biological markers in patients with follicular lymphoma treated on clinical trial SWOG-8809, SWOG-9800, or SWOG-9911.


Condition Intervention
Lymphoma Genetic: microarray analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: Assessment of MUM1 Expression, Lymphoma-Associated Macrophages, and Regulatory T-Cells in Follicular Lymphoma: Prognostic Markers in SWOG S8809 and S9800/S9911 Trials Representing Pre-and Post-Monoclonal Antibody Therapy Protocols

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Prognostic significance of MUM-1, lymphoma-associated macrophages, and regulatory T cells [ Time Frame: Retrospective ]
  • Comparison of prognostic significance in patients treated with chemotherapy alone vs chemotherapy and monoclonal antibody therapy [ Time Frame: Retrospective ]

Enrollment: 180
Study Start Date: January 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the prognostic significance of MUM-1, lymphoma-associated macrophages, and regulatory T cells in patients with follicular lymphoma treated on clinical trials SWOG-8809, SWOG-9800, or SWOG-9911 representing pre- and post-monoclonal antibody therapy protocols.
  • Determine whether these factors have similar prognostic significance in patients treated with chemotherapy alone vs chemotherapy and monoclonal antibody therapy on these clinical trials.

OUTLINE: This is a multicenter study.

Previously collected tissue samples from patients are analyzed by immunohistochemistry, gene expression profiling, and quantitative analysis for MUM1 expression, lymphoma-associated macrophages, FOXP3-positive regulatory T cells, CD68, and CD163.

PROJECTED ACCRUAL: A total of 318 samples will be accrued for this study.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients enrolled to S8809, S9800 and S9911 consenting to banking
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of follicular lymphoma
  • Previously treated on any of the following clinical trials:

    • SWOG-8809
    • SWOG-9800
    • SWOG-9911

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): NCT00896922


Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: John W. Sweetenham, MD The Cleveland Clinic
  More Information

Publications:
Sweetenham JW, Hsi E, Goldman B, et al.: Numbers of lymphoma associated macrophages (LAMS) and regulatory T-cells (Tregs) in follicular lymphoma (FL) patients (pts) treated with and without monoclonal antibody (MoAb)-containing therapy do not correlate with overall survival (OS): a study from the Southwest Oncology Group (SWOG). [Abstract] Blood 110 (11): A-2602, 2007.

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00896922     History of Changes
Other Study ID Numbers: CDR0000530630
SWOG-S8809/S9800
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: February 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://swog.org/Visitors/Download/Policies/Policy43.pdf

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Southwest Oncology Group:
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma

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