Longitudinal Changes in Serum KL-6 Levels in Idiopathic Pulmonary Fibrosis (LOCK-IPF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Serum KL-6 level
研究概览
简要总结
Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease with a poor prognosis. More accurate tests to predict disease progression and response to treatment are required.
Krebs von den Lungen-6 (KL-6) is a blood marker associated with IPF. Results from previous studies have shown that levels of KL-6 are higher in patients with IPF compared to people without the disease. In addition, it is not clear what impact treatment has on KL-6 levels, and whether this could help us to monitor how effective treatment for IPF is.
The investigators plan to perform a study in which KL-6 levels in the blood of patients with a new diagnosis of IPF are measured at baseline, 3, 6 and 12 months to look for and changes in the levels of KL-6 in the blood.
详细描述
Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease with a poor prognosis. Effective treatment which slows the progression of IPF has recently become available however, it is costly and at present is limited to patients who meet specific criteria based on their breathing tests. The breathing tests currently available to monitor progression of the disease are not always reliable and do not predict which patients will respond to treatment. More accurate tests to predict disease progression and response to treatment are required.
Krebs von den Lungen-6 (KL-6) is a blood marker associated with IPF. Results from previous studies have shown that levels of KL-6 are higher in patients with IPF compared to people without the disease. The majority of studies using KL-6 in IPF have taken place in Japan and there is limited evidence of how useful it is in a European population. In addition, it is not clear what impact treatment has on KL-6 levels, and whether this could help us to monitor how effective treatment for IPF is.
The investigators plan to perform a study in which KL-6 levels in the blood of patients with a new diagnosis of IPF are measured at baseline, 3, 6 and 12 months to look for and changes in the levels of KL-6 in the blood
The objective of this study is to assess changes in serum KL-6 levels in patients with IPF over a 12-month period and assess if this correlates with changes in lung function and if KL-6 levels change in response to treatment with antifibrotic therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age 18 or older
- •Multi-disciplinary team (MDT) diagnosis of idiopathic pulmonary fibrosis as per international consensus guidelines
- •Exclusion criteria
- •Significant respiratory co-morbidity (i.e. where the major respiratory diagnosis is not IPF)
- •FEV1/FVC ratio < 70% on full lung function testing
- •Current smoker (within 4 week of enrollment)
- •Received treatment for acute lower respiratory tract infection with last 4 weeks
- •Use of long-term (greater than 4 weeks) oral corticosteroids or immunosuppression within 4 weeks of enrolment
- •Current participation in a double-blind placebo-controlled pharmaceutical trial
排除标准
- 未提供
结局指标
主要结局
Serum KL-6 level
时间窗: 12 months
Change in serum KL-6 level between baseline and 12 months
次要结局
- KL-6 Gender Age and Physiology (GAP) stage(At baseline)
- KL-6 forced vital capacity (FVC) correlation(3, 6 and12 months)
- KL-6 diffusion capacity (DLCO)(3, 6 and12 months)
- KL-6 antifibrotics(12 months)
- KL-6 CPI(At baseline)
- Serum KL-6 level at 3, 6 months(3 and 6 months)
- KL-6 CT pattern(At baseline)
- KL-6 symptoms(3, 6 and12 months)