Sequential Changes of Serum KL-6 Predict Progression in Interstitial Lung Disease

• Conditions: Interstitial Lung Disease, Desquamative

• Registration Number: NCT02960672
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Brief Summary

Interstitial lung disease is a chronic progressive fibrosis lung disease that with a highly variable clinical process.thence it is significant for the patient to search a convenient and accurate prediction method. The objective of this study was to determine whether peripheral blood biomarkers can predict disease .

Detailed Description

The median follow-up period was 12 months, each patient received 4 or 5 follow-ups in our center, 336 person-times in study enrollment totally. The patients with interstitial lung disease had significantly higher serum baseline KL-6 and MMP-7 levels compared with healthy control.They divided into progressive group and non-progressive group according to disease change. Serum KL-6 and MMP-7 levels were elevated in patients if disease progression, but baseline level of biomarkers in progressive group were not significant higher compare with non-progressive group .Binary logistic regression showed △KL-6 and △MMP-7 were significant predictors for disease progression. Multivariate Cox analysis showed KL-6 and MMP-7 were significantly associated with survival along with other variables.

The serum levels of KL-6 and MMP-7 were elevated in the individuals with interstitial lung disease compared with healthy controls. The rate of poor prognosis and mortality more associated with the variability increased biomarker concentrations，rather than the baseline concentration.Therefore，Serial measurements of biomarkers contribute to the disease monitoring in clinical management.

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2016-10
• Study First Submitted: 2016-10-27
• Status Verified: 2016-11
• Study First Submitted QC: 2016-11-07
• Last Update Submitted: 2016-11-07
• Study First Posted: 2016-11-10
• Last Update Posted: 2016-11-10
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

• Diagnosise of interstitial lung disease acute excerbation
• Combined pulmonary embolism, pulmonary edema, pulmonary tuberculosis, and peumonias

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sequential Changes of Serum KL-6 Predict Progression in Interstitial Lung Disease	3 years	Serum samples were prospectively collected from 70 patients including baseline, 1 month, 2 months, 6 months and 12 months, which were tested for a panel of Krebs van den Lungen-6 antigen (KL-6), by latex agglutination test.We have demonstrated that an increase in serum KL-6 levels, but not the level at any one point in time, predicts poor prognosis.

Secondary Outcome Measures

Name	Time	Method
Sequential Changes of Serum MMP-7 Predict Progression in Interstitial Lung Disease	3 years	Serum samples were prospectively collected from 70 patients including baseline, 1 month, 2 months, 6 months and 12 months, which were tested for a panel of matrix metalloproteinase-7 (MMP-7), by ELISA-based.We have demonstrated that an increase in serum MMP-7 levels, but not the level at any one point in time, predicts poor prognosis.

Trial Locations

Locations (1)

Ying Jiang; 🇨🇳 Guanzhou, Guangdong, China