Assessment of the Tissue and Serum Level of NLRP1, NLRP3 Inflammasomes and Interleukin-18 in Early Stages of Mycosis Fungoids Patients Before and After Different Treatment Modalities: Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- To compare tissue and serum level of NLRP1, NLRP3 inflammasomes and Interleukin (IL)-18 in mycosis fungoids patients and normal controls.
研究概览
简要总结
To compare tissue and serum level of NLRP1, NLRP3 inflammasomes and Interleukin (IL)-18 in mycosis fungoids patients and normal controls.
To compare tissue and serum level of NLRP1, NLRP3 inflammasomes and Interleukin (IL)-18 in mycosis fungoids patients before and after different treatment modalities.
详细描述
Thirty patients with early stage mycosis fungoids and thirty normal healthy controls will be recruited. An informed written consent will be obtained from all patients and controls.
Data collection Demographic data Each patient will be subjected to detailed history taking as regards age, sex, residence, marital status, smoking, special habits of medical importance, duration of the disease, associated diseases, previous therapy and family history.
Evaluation of the clinical response The patients will be photographed and evaluated at baseline and at the end of treatment .
Clinical scoring of five mycosis fungoids skin lesions will be done using Composite assessment of index lesion severity (CAILS) (Oslen et al., 2011).
Clinical scoring of whole body affection will be done using Modified Severity Weighted Assessment tool (MSWAT) (Oslen et al., 2011).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •New patients with early stages of mycosis fungoids (patch and plaque stage).
- •Both genders
- •Age group ≥ 18 years old.
排除标准
- •Patients with late stages mycosis fungoids (Tumor stage).
- •Patients with absolute contraindication to phototherapy (e.g. any other skin cancers or photosensitivity); or to psoralen (e.g. liver disease).
- •Subjects with history of solid or hematological malignancy as leukemia.
- •Patients with autoimmune disease (e.g. SLE).
- •Patients who received treatment of mycosis fungoids for the past one month.
- •Pregnant and lactating females.
结局指标
主要结局
To compare tissue and serum level of NLRP1, NLRP3 inflammasomes and Interleukin (IL)-18 in mycosis fungoids patients and normal controls.
时间窗: 4 months
Diagnostic
次要结局
- To compare tissue and serum level of NLRP1, NLRP3 inflammasomes and Interleukin (IL)-18 in mycosis fungoids patients before and after different treatment modalities.(4 months)
- Correlating tissue and serum level of NLRP1, NLRP3 inflammasomes and Interleukin (IL)-18 in mycosis fungoids patients with patient's age, sex, duration of disease, extent of disease.(4 months)
研究者
Nourhan Emad
Assistant lecturer
Cairo University