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

Shanghai Pulmonary Hospital, Shanghai, China

Status: Completed

Conditions: Interstitial Lung Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02197364

KL-6_20140715

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,190 patients

Sex: All

Ages: 14 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,190 participants in 1 patient group

ILD, Other respiratory diseases, Healthy control group

Description:

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.