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

November 7, 2016 updated by: Ying Jiang, The First Affiliated Hospital of Guangzhou Medical University
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 .

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guanzhou, Guangdong, China, 510000
        • Ying Jiang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All subjects with a diagnosis of idiopathic interstitial pneumonias made in accordance with the American Thoracic Society (ATS)/European Respiratory Society (ERS) consensus classification

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sequential Changes of Serum KL-6 Predict Progression in Interstitial Lung Disease
Time Frame: 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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sequential Changes of Serum MMP-7 Predict Progression in Interstitial Lung Disease
Time Frame: 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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

October 1, 2016

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 27, 2016

First Submitted That Met QC Criteria

November 7, 2016

First Posted (Estimate)

November 10, 2016

Study Record Updates

Last Update Posted (Estimate)

November 10, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • gyfyy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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