The Role of KL-6 as a Serum Biomarker in the Clinical Diagnosis of Interstitial Lung Diseases (ILD) in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,190
- 主要终点
- The KL-6 concentration on the immune analyzer
研究概览
简要总结
The purpose of the study is to evaluate the significance of KL-6 as a biomarker in the clinical diagnosis of interstitial lung disease (ILD) by detecting serum KL-6 levels among patients with ILD, and comparing them to the clinical diagnostic criteria and other respiratory diseases. In addition, the study discusses the value of KL-6 levels in terms of ILD treatment effect evaluation through the detection of serum KL-6 levels before treatment and after treatment.
详细描述
As a multi-center, double-blind clinical study, the trial is divided into two parts.
Part 1: The purpose of this part is to evaluate the role of KL-6 as a biomarker in the clinical diagnosis of interstitial lung disease (ILD) by detecting serum KL-6 levels among patients with ILD, and comparing them to the clinical diagnostic criteria and other respiratory diseases, including pulmonary tuberculosis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease and healthy control group.
Part 2: The purpose of this part is to study the value of KL-6 levels in terms of ILD treatment effect evaluation through the detection of serum KL-6 levels before treatment and 30-90 days after treatment. Treatment includes anti fibrosis, anti-inflammatory and other conventional therapies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 14 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Serums from patients with ILD, pulmonary tuberculosis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease and health
- •Serums from patients with ILD: before treatment and 30-90 days after treatment
排除标准
- •Serums from patients with cancer
- •Serums with visible precipitate
- •Serums with floc
结局指标
主要结局
The KL-6 concentration on the immune analyzer
时间窗: The serum from patients with ILD will be collected for the duration of hospital stay, an average of 4 weeks
Detect the KL-6 concentration in serum by the use of the immune analyzer among patients with ILD.
次要结局
- The KL-6 concentration on the immune analyzer(The serum from healthy people will be collected for the duration of physical examination, an average of 1 day)
- Change of KL-6 concentration on the immune analyzer(pretherapy, 30-90 days after treatment)
研究者
Huiping Li
Professor,Chief of Dept. of Respiratory Medicine
Shanghai Pulmonary Hospital, Shanghai, China