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

Interstitial Lung Disease, Desquamative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02960672
• Other study ID #: gyfyy
• Status: Active, not recruiting
• Phase: N/A
• First received: October 27, 2016
• Last updated: November 7, 2016
• Start date: March 2013
• Est. completion date: December 2018

Study information

• Verified date: November 2016
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: December 2018
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 68 Years

Eligibility

Inclusion Criteriar:

• Clinical diagnosis of interstitial lung disease

Exclusion Criteria:

• Diagnosise of interstitial lung disease acute excerbation

• Combined pulmonary embolism, pulmonary edema, pulmonary tuberculosis, and peumonias

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disease Progression
• Genetic Diseases, Inborn
• Interstitial Lung Disease, Desquamative
• Lung Diseases
• Lung Diseases, Interstitial

Locations

Country	Name	City	State
China	Ying Jiang	Guanzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sequential Changes of Serum KL-6 Predict Progression in Interstitial Lung Disease	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.	3 years	Yes
Secondary	Sequential Changes of Serum MMP-7 Predict Progression in Interstitial Lung Disease	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.	3 years	Yes