Gene Expression Analysis in Cutaneous T-Cell Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Analyzing genes that are present in cancer cells may be useful in developing better methods to detect, predict, and treat cutaneous T-cell lymphoma.
PURPOSE: Clinical trial to study genes that are present in cutaneous T-cell lymphoma cells.
详细描述
OBJECTIVES:
- Identify gene expression patterns in malignant T cells that can be used to diagnose cutaneous T-cell lymphoma.
- Determine the patterns of gene expression that distinguish normal skin-homing T cells from malignant T cells.
OUTLINE: Patients are stratified by disease (Sezary syndrome vs mycosis fungoides) and prior treatment (yes vs no).
All patients receive a physical examination, and a medical history is taken. Patients with Sezary syndrome undergo leukapheresis. Patients with plaque/tumor stage mycosis fungoides undergo skin biopsy of involved skin. Malignant T cells from blood or skin are then isolated and patterns of gene expression in the malignant T cells are compared to those in normal skin-homing T cells from healthy donors using a "gene chip" (Lymphochip).
Patients are followed annually for 5 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Diagnostic
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven mycosis fungoides with 2 or more plaques or tumors greater than 1 cm in size OR
- •Immunologically proven Sezary syndrome with all of the following:
- •Erythroderma
- •Lymphadenopathy
- •T-cell receptor variable beta chain clonality greater than 10% of total lymphocytes by flow cytometry OR
- •CD4+CD7- T-cell fraction that represents greater than 10% of CD4+ T cells
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •See Disease Characteristics
- •Not specified
- •Not specified
- •Not pregnant or nursing
- •HIV-1 and HTLV-1 negative
- •No prior intravenous drug use
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 2 months since prior systemic chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 2 months since prior electron beam radiotherapy
- •Not specified
- •At least 2 weeks since prior topical therapy
- •At least 2 months since prior photopheresis
- •At least 2 months since prior psoralen ultraviolet light (PUVA) or ultraviolet B (UVB) therapy
排除标准
- 未提供
