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

NCT ID: NCT02197364

Last Updated: 2014-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1190 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-05-31

Brief Summary

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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

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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.

Conditions

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Interstitial Lung Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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ILD, Other respiratory diseases, Healthy control group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujirebio Diagnostics, Inc.

INDUSTRY

Sponsor Role collaborator

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role lead

Responsible Party

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Huiping Li

Professor,Chief of Dept. of Respiratory Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li Hui Ping

Role: PRINCIPAL_INVESTIGATOR

Shanghai Pulmonary Hospital , Tongji University

Other Identifiers

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KL-6_20140715

Identifier Type: -

Identifier Source: org_study_id

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