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

NCT ID: NCT00896922

Last Updated: 2017-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lymphoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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microarray analysis

Intervention Type GENETIC

immunohistochemistry staining method

Intervention Type OTHER

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

16 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John W. Sweetenham, MD

Role: STUDY_CHAIR

The Cleveland Clinic

References

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Sweetenham JW, Goldman B, LeBlanc ML, Cook JR, Tubbs RR, Press OW, Maloney DG, Fisher RI, Rimsza LM, Braziel RM, Hsi ED. Prognostic value of regulatory T cells, lymphoma-associated macrophages, and MUM-1 expression in follicular lymphoma treated before and after the introduction of monoclonal antibody therapy: a Southwest Oncology Group Study. Ann Oncol. 2010 Jun;21(6):1196-1202. doi: 10.1093/annonc/mdp460. Epub 2009 Oct 29.

Reference Type RESULT
PMID: 19875761 (View on PubMed)

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.

Reference Type RESULT

Other Identifiers

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SWOG-S8809/S9800

Identifier Type: -

Identifier Source: secondary_id

CDR0000530630

Identifier Type: -

Identifier Source: org_study_id

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