NCT03103191Unknown不适用
Diagnostic Value of KL-6 in Interstitial Lung Diseases
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2016年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Serum KL-6 levels in patients with pulmonary fibrosis at the time of diagnosis.
研究概览
简要总结
KL-6 may be a useful biomarker in patients with interstitial lung disease, but there is limited information in non-Asian populations. Therefore, it is necessary to carry out studies in other populations to confirm the diagnostic values of the biomarker and its prognostic implication.
Hypothesis KL-6 may be a useful biomarker in the management of interstitial lung diseases. But it is necessary to know more about its utility in the European population.
Study Objectives:
- To determine the concentration of KL-6 in serum of patients with pulmonary fibrosis at the time of diagnosis compared to patients without pulmonary fibrosis
- Diagnostic yield of KL-6 in patients with pulmonary fibrosis.
- Correlation of KL-6 values with functional and radiological parameters of disease severity at diagnosis.
- Correlation of serum KL-6 values with the evolution of the disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects older than 18 years.
- •Chronic respiratory diseases )including Fibrotic interstitial lung disease, asthma or COPD) related or not to a connective tissue disease.
- •Acceptance of the patient to participate in the study by signing the informed consent after having discussed with the researchers the objectives, risks and potential benefits.
排除标准
- •Absence of informed consent
- •Psychiatric disorder or limitation of collaboration (including language, socio-cultural problem, etc.).
结局指标
主要结局
Serum KL-6 levels in patients with pulmonary fibrosis at the time of diagnosis.
时间窗: Baseline
次要结局
未报告次要终点
研究者
研究点 (1)
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