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

NCT ID: NCT02960672

Last Updated: 2016-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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

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Interstitial Lung Disease, Desquamative

Keywords

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KL-6 disease progression predict biomarkers MMP-7

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of interstitial lung disease

Exclusion Criteria

* Diagnosise of interstitial lung disease acute excerbation
* Combined pulmonary embolism, pulmonary edema, pulmonary tuberculosis, and peumonias
Minimum Eligible Age

40 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ying Jiang

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ying Jiang

Guanzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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gyfyy

Identifier Type: -

Identifier Source: org_study_id