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临床试验/NCT00020072
NCT00020072已完成不适用

Gene Expression Analysis in Cutaneous T-Cell Lymphoma

National Cancer Institute (NCI)1 个研究点 分布在 1 个国家开始时间: 2000年3月1日最近更新:
适应症

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

研究者

申办方类型
Nih

研究点 (1)

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