Clinical Trials Directory

Trials / Unknown

UnknownNCT02960672

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

Status
Unknown
Phase
Study type
Observational
Enrollment
70 (actual)
Sponsor
The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
Sex
All
Age
40 Years – 68 Years
Healthy volunteers
Accepted

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.

Conditions

Timeline

Start date
2013-03-01
Primary completion
2016-10-01
Completion
2018-12-01
First posted
2016-11-10
Last updated
2016-11-10

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT02960672. Inclusion in this directory is not an endorsement.