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临床试验/NCT03101397
NCT03101397Unknown不适用

The Clinical Value of Serum KL-6 Changes on Evaluating Disease Development in Different Diffuse Parenchymal Lung Disease

The First Affiliated Hospital of Guangzhou Medical University1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
180
试验地点
1
主要终点
Serum KL-6

研究概览

简要总结

Diffuse Parenchymal Lung Disease(DPLD) is a chronic progressive fibrosis lung disease that with a highly variable clinical process.Krebs von den Lungen-6 (KL-6) is a high-molecular-weight glycoprotein, classified as human MUC1 mucin, that is produced mainly by regenerating type II pneumocytes.Serum levels of KL-6 have been shown to be elevated in patients with DPLD and could predict progress, but unaware of the differential threshold. The objective of this study was to perspectively and sequentially monitor serum KL-6 levels in patients with different DPLD,then analyze its clinical value and find the differential threshold.

详细描述

Subjects and Method: Recruiting different DPLD patients in our hospital between 2013 February and 2016 October, including polymyositis/dermatomyositis related interstitial lung disease (PM/DM-ILD), rheumatoid arthritis related interstitial lung disease (RA - ILD), interstitial pneumonia with autoimmune features(IPAF) and idiopathic pulmonary fibrosis(IPF), following up for enery 3 to 6 months. Once condition deteriorated, patient could return at any time if necessary according to our clinical physician judgment. Tumor markers,pulmonary function test(PFT); chest thin-section CT examination and CT scores; serum KL-6 levels were acquired in all patients at baseline and follow-ups. Serum KL-6 was measured on LUMIPULSE G System(FUJIREBIO, JAPAN) by chemiluminescence enzyme immunoassay. All follow-up patients will be respectively divided into improved,stable and deteriotated group according to the official ATS/ERS statement.

Inclusion criteria: (1)patient with PM/DM-ILD, RA-ILD, IPAF, IPF.The diagnosis of patient were according to the official ATS/ERS statement and the American College of Rheumatology/European League standard;(2)18 to 80 years old.

Exclusion criteria: (1)conbination with pulmonary tubenculersis,pulmonary infection,tumor;(2)no serum KL-6 or pulmonary function test or chest thin-section CT examintion ;(3)patient with severe hepatic and renal dysfunction,heart disease or receiving hemodialysis treatment;(4)pregnant or plan to be pregnant

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of PM/DM-ILD,RA-ILD,IPAF,IPF

排除标准

  • Combined with pulmonary infection,pulmonary tuberculosis,carsinoma.

结局指标

主要结局

Serum KL-6

时间窗: 3 years

serum samples were prospectively cellected from 180 patients at baseline and follow-ups. Serum KL-6 was measured on LUMIPULSE G System(FUJIREBIO, JAPAN) by chemiluminescence enzyme immunoassay.

次要结局

  • Diffusing capacity for carbon monoxide(DLCO)(3 years)
  • Forced vital capacity(FVC)(3 years)
  • CT score(3 years)

研究者

发起方
The First Affiliated Hospital of Guangzhou Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

chen miao

Principal Investigator

The First Affiliated Hospital of Guangzhou Medical University

研究点 (1)

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