Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03101397
Enrollment
180
Registered
2017-04-05
Start date
2013-02-28
Completion date
2018-12-31
Last updated
2017-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Parenchymal Lung Disease

Keywords

serum KL-6, pulmonary function test, CT score, evaluation

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

Interventions

None listed

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Combined with pulmonary infection,pulmonary tuberculosis,carsinoma.

Design outcomes

Primary

MeasureTime frameDescription
Serum KL-63 yearsserum 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.

Secondary

MeasureTime frameDescription
Forced vital capacity(FVC)3 yearsAll 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.
Diffusing capacity for carbon monoxide(DLCO)3 yearsAll 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.
CT score3 yearsAll 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026