Diffuse Parenchymal Lung Disease Clinical Trial
Official title:
The Clinical Value of Serum KL-6 Changes on Evaluating Disease Development in Different Diffuse Parenchymal Lung Disease
Verified date | April 2017 |
Source | The First Affiliated Hospital of Guangzhou Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 180 |
Est. completion date | December 2018 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of PM/DM-ILD,RA-ILD,IPAF,IPF Exclusion Criteria: - Combined with pulmonary infection,pulmonary tuberculosis,carsinoma. |
Country | Name | City | State |
---|---|---|---|
China | First Affiliated Hospital of Guangzhou Medical university | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Guangzhou Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum KL-6 | 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. | 3 years | |
Secondary | Forced vital capacity(FVC) | All patient were underwent spirometry examination on COSMED spirometer at baseline and follow-ups.Forced vital capacity(FVC)and the percentages of predicting value (FVC%pre) were recorded. | 3 years | |
Secondary | Diffusing capacity for carbon monoxide(DLCO) | All patient were underwent diffusion capacity examination by intra-breath method on COSMED spirometer at baseline and follow-ups.Diffusing capacity for carbon monoxide(DLCO)and the percentages of predicting value (DLCO%pre) were recorded. | 3 years | |
Secondary | CT score | All chest CT was obtained with 1 or 2 mm sequentially throughout the entire lung at baseline and follow-ups.CT scans were reviewed independtly by two thracic radiologists without knowledge of clinical,physiologic,or pathologic parameters,at a window level of -650 H and a window width of 1200 H. Obsevers were also kept unaware of patient diagnose.The whole lung were divided into six areas at the level of the aortic arch and inferior pulmonary vein.Each erea was scored on a scale of 0-10. | 3 years |
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