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

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.

Study Overview

• Status: Unknown
• Conditions: Diffuse Parenchymal Lung Disease

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

• Study Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All subjects with a dignosis of DPLD refer to the American Thracic Society(ATS)/European Respiratory Society(ERS) or American College of Rheumatology statement.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Combined with pulmonary infection,pulmonary tuberculosis,carsinoma.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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)
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).
stable group; not included in improved group or deteriorated group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): October 1, 2016
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: March 29, 2017
• First Posted (Actual): April 5, 2017

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 11, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: evaluation; pulmonary function test; serum KL-6; CT score
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: gyfyy-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No