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NCT02197364 Clinical Trial

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

Interstitial Lung Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02197364
Other study ID # KL-6_20140715
Secondary ID
Status Completed
Phase N/A
First received July 16, 2014
Last updated July 18, 2014
Start date December 2013
Est. completion date May 2014

Study information
Verified date July 2014
Source Shanghai Pulmonary Hospital, Shanghai, China
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1190
Est. completion date May 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 14 Years to 90 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Shanghai Pulmonary Hospital, Shanghai, China Fujirebio Diagnostics, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
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