jRCT1030230668招募中不适用
Clinical performance study of AIA-CL PS-PLA1 (Phosphatidylserine-specific Phos pholipase A1) assay reagent for systemic lupus erythematosus (SLE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 主要终点
- -
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
- No limit 至 No limit（—）
入选标准
- •SLE patients (untreated, treated intervention), non-SLE connective tissue disease patients (rheumatoid arthritis, other antinuclear antibody-related connective tissue diseases [Sjogren's syndrome, systemic sclerosis, polymyositis/dermatomyositis, mixed connective tissue disease], antiphospholipid antibody syndrome), non-connective tissue disease subjects
排除标准
- •Patients with thyroid disorders (Graves' disease, thyroiditis, Plummer's disease, Hashimoto's disease)
- •Pregnant women
- •Non-connective tissue disease subjects who are antinuclear antibody positive
结局指标
主要结局
-
Discriminatory evaluation of SLE using PS-PLA1
次要结局
- Sensitivity, specificity, positive predictive value, negative predictive value, and area under the curve (AUC) by ROC analysis
- Transition of PS-PLA1, anti-ds-DNA antibodies, and SLEDAI values
研究者
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