The Role of KL-6 in the Clinical Diagnosis of ILD

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the significance of KL-6 as a biomarker in the clinical diagnosis of interstitial lung disease (ILD) by detecting serum KL-6 levels among patients with ILD, and comparing them to the clinical diagnostic criteria and other respiratory diseases. In addition, the study discusses the value of KL-6 levels in terms of ILD treatment effect evaluation through the detection of serum KL-6 levels before treatment and after treatment.

Detailed Description
-----------------
As a multi-center, double-blind clinical study, the trial is divided into two parts. Part 1: The purpose of this part is to evaluate the role of KL-6 as a biomarker in the clinical diagnosis of interstitial lung disease (ILD) by detecting serum KL-6 levels among patients with ILD, and comparing them to the clinical diagnostic criteria and other respiratory diseases, including pulmonary tuberculosis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease and healthy control group. Part 2: The purpose of this part is to study the value of KL-6 levels in terms of ILD treatment effect evaluation through the detection of serum KL-6 levels before treatment and 30-90 days after treatment. Treatment includes anti fibrosis, anti-inflammatory and other conventional therapies.

Official Title
-----------------
The Role of KL-6 as a Serum Biomarker in the Clinical Diagnosis of Interstitial Lung Diseases (ILD) in China

Conditions
-----------------
Interstitial Lung Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Serums from patients with ILD, pulmonary tuberculosis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease and health Serums from patients with ILD: before treatment and 30-90 days after treatment Exclusion Criteria: Serums from patients with cancer Serums with visible precipitate Serums with floc

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ILD, Other respiratory diseases, Healthy control group<br>ILD: those with interstitial lung disease. Other respiratory diseases: those with other respiratory disease including pulmonary tuberculosis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease. Healthy control group: those who is healthy. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The KL-6 concentration on the immune analyzer | Detect the KL-6 concentration in serum by the use of the immune analyzer among patients with ILD. | The serum from patients with ILD will be collected for the duration of hospital stay, an average of 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The KL-6 concentration on the immune analyzer | Detect the KL-6 concentration in serum by the use of the immune analyzer among patients with other respiratory diseases, including pulmonary tuberculosis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease. | The serum from patients other respiratory diseases will be collected for the duration of hospital stay, an average of 4 weeks | 
| The KL-6 concentration on the immune analyzer | Detect the KL-6 concentration in serum by the use of the immune analyzer among healthy people. | The serum from healthy people will be collected for the duration of physical examination, an average of 1 day | 
| Change of KL-6 concentration on the immune analyzer | Change of KL-6 concentration on the immune analyzer from pretherapy to 30-90 days after treatment among patients with ILD. | pretherapy, 30-90 days after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interstitial Lung Disease, Diagnosis, Krebs Von Den Lungen-6