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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00896922
Other study ID # CDR0000530630
Secondary ID SWOG-S8809/S9800
Status Completed
Phase N/A
First received May 9, 2009
Last updated February 24, 2017
Start date January 2007
Est. completion date October 2009

Study information

Verified date February 2017
Source Southwest Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender All
Age group 16 Years to 120 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
microarray analysis

Other:
immunohistochemistry staining method

laboratory biomarker analysis


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Southwest Oncology Group National Cancer Institute (NCI)

References & Publications (2)

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 an — View Citation

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 wi

Outcome

Type Measure Description Time frame Safety issue
Primary Prognostic significance of MUM-1, lymphoma-associated macrophages, and regulatory T cells Retrospective
Primary Comparison of prognostic significance in patients treated with chemotherapy alone vs chemotherapy and monoclonal antibody therapy Retrospective
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