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临床试验/NCT04491825
NCT04491825Unknown不适用

Diagnostic Classifier for Cutaneous T-cell Lymphomas

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2021年2月22日最近更新:
适应症

试验速览

阶段
不适用
入组人数
160
试验地点
1
主要终点
Proteomic signature of MF in comparison to eczema, psoriasis, and healthy control skin

研究概览

简要总结

Primary cutaneous T-cell lymphomas (CTCL) are a form of skin cancer that is derived from immune cells. The most common form of CTCL is mycosis fungoides (MF). While initially confined to the skin, MF may spread to lymph nodes, blood or inner organs, resulting in an overall poor prognosis for the patient. Thus, being a potentially lethal disease, an early and correct diagnosis of MF has very important implications for the patient. However, diagnosis of early MF is often difficult, as it usually shows a close resemblance to benign inflammatory conditions such as eczema and psoriasis. Strikingly, it takes an average of 3-6 (!) years from the appearance of the first skin lesions until a diagnosis of MF can be made. For this reason, a test to distinguishing early MF from benign inflammatory conditions is urgently mandated. By using skin suction blister fluid as well as skin biopsies from patients with MF, eczema and psoriasis, the investigators want to develop a classifier system that can distinguish early MF from benign inflammatory skin diseases.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical and/or histopathological diagnosis of MF, eczema or psoriasis
  • Healthy control subjects without personal history of MF, eczema or psoriasis

排除标准

  • Ongoing skin-targeted treatment (Wash out times: 2 weeks for topical, and 4 weeks for systemic treatments)
  • Ongoing other treatment that might, in the opinion of the investigator, influence proteomic features of the samples to be acquired

结局指标

主要结局

Proteomic signature of MF in comparison to eczema, psoriasis, and healthy control skin

时间窗: At baseline

Proteomic multiplex assay

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Patrick M. Brunner

Associate Professor

Medical University of Vienna

研究点 (1)

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