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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02197364

Enrollment

1190

Registered

2014-07-22

Start date

2013-12-31

Completion date

2014-05-31

Last updated

2014-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Disease

Keywords

Interstitial Lung Disease, Diagnosis, Krebs Von Den Lungen-6

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to 90 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
The KL-6 concentration on the immune analyzer	The serum from patients other respiratory diseases will be collected for the duration of hospital stay, an average of 4 weeks	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.
Change of KL-6 concentration on the immune analyzer	pretherapy, 30-90 days after treatment	Change of KL-6 concentration on the immune analyzer from pretherapy to 30-90 days after treatment among patients with ILD.

Outcome results