NL-OMON53930已完成不适用
A single-centre, exploratory study to characterise the skin barrier and microbiome of patients with cutaneous T-cell lymphoma (CTCL) - Skin barrier and microbiome of CTCL patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a patient must meet all
- •of the following criteria at all visits:
- •1. Able to understand and provide a written informed consent prior to any study
- •2. Male or female subjects, 18 years or older.
- •3. A confirmed diagnosis of CTCL (MF type or SS type), and stage classification
- •via histology or clinico-histopathological correlation.
- •4. For the stage IA-IIA CTCL patients: at least one patch and/or one plaque
- •lesion are present,
- •with at least one dimension with a diameter of >=3 cm.
- •For the stage IIB and higher classified (non-tumour) CTCL patients: at least
- •and/or one plaque lesion are present, with at least one dimension with a
- •diameter of >=3 cm
- •For the stage IIB and higher classified (tumour) CTCL patients: at least one
- •present, with at least one dimension with a diameter of >=1.5 cm.
- •For the Sezary Syndrome patients: at least one patch and/or one plaque lesion
- •are present,
- •with at least one dimension with a diameter of >=3 cm OR at least one tumour is
- •present, with
- •at least one dimension with a diameter of >=1.5 cm.
排除标准
- •A potential patient who meets any of the following criteria will be excluded
- •from participation in this study:
- •1. Use of topical antibiotic (on selected target lesions) and/or oral
- •antibiotic therapy in the previous 14 days before the visit.
- •2. Clinically significant skin disease on the selected lesions, other than CTCL
- •or CTCL associated secondary impetiginisation, as judged by the investigator.
- •3. Ongoing active skin infection, other than secondary impetiginized CTCL
- •4. Treatment of selected target CTCL lesions with radiotherapy within 8 weeks
- •prior to Day 1.
- •5. Any other clinical condition that may preclude participation in the study as
- •judged by the investigator
研究者
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