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

NCT ID: NCT03101397

Last Updated: 2017-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2018-12-31

Brief Summary

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.

Detailed Description

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

Conditions

Diffuse Parenchymal Lung Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

improved group

defined by two or more of the following: A decrease in symptoms, specifically an increase in the level of exertion required before the patient must stop because of breathlessness or a decline in the frequency or severity of cough Reduction of parenchymal abnormalities on chest CT scan Physiologic improvement defined by \> 10% increase in FVC (or at least \> 200-ml change) or \> 15% increase in single-breath DLCO (or at least \> 3 ml/min/mm Hg)

No interventions assigned to this group

deteriorated group

defined by two or more of the following: An increase in symptoms, especially dyspnea or cough; An increase in opacities on chest CT scan, especially the development of honeycombing ; deterioration in lung function with \> 10% decrease in FVC ( or \> 200ml change) or \> 15% decrease in DLCO (or at least \> 3ml/min/mm Hg change).

No interventions assigned to this group

stable group

not included in improved group or deteriorated group

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Combined with pulmonary infection,pulmonary tuberculosis,carsinoma.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

chen miao

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

First Affiliated Hospital of Guangzhou Medical university

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

gyfyy-2017

Identifier Type: -

Identifier Source: org_study_id