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

NCT03101397 | Unknown

• 1 other identifier: gyfyy-2017
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Parenchymal Lung Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Forced vital capacity（FVC）

  3 years

• Diffusing capacity for carbon monoxide（DLCO）

  3 years

• CT score

  3 years

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Combined with pulmonary infection,pulmonary tuberculosis,carsinoma.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

First Affiliated Hospital of Guangzhou Medical university

Guangzhou, Guangdong, 510120, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood biomakers

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: April 5, 2017
• Study Start: February 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2018
• Last Updated: April 13, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)