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

July 18, 2014 updated by: Huiping Li, Shanghai Pulmonary Hospital, Shanghai, China

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1190

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The serums from clinical laboratory of Shanghai Pulmonary Hospital, Nanjing Drum Tower Hospital and Beijing Chaoyang Hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The KL-6 concentration on the immune analyzer
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: The serum from healthy people will be collected for the duration of physical examination, an average of 1 day
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
Time Frame: 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.
pretherapy, 30-90 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Collaborators

Fujirebio Diagnostics, Inc.

Investigators

  • Principal Investigator: Li Hui Ping, Shanghai Pulmonary Hospital , Tongji University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

July 16, 2014

First Submitted That Met QC Criteria

July 18, 2014

First Posted (Estimate)

July 22, 2014

Study Record Updates

Last Update Posted (Estimate)

July 22, 2014

Last Update Submitted That Met QC Criteria

July 18, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KL-6_20140715

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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