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NCT Number: NCT02197364

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

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.

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Key information

Conditions

Interstitial Lung Disease Disease Lung Diseases Lung Diseases, Interstitial Medullary cystic kidney disease 1 Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

14 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Collaborators

  • Fujirebio Diagnostics, Inc.

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 22, 2014
Registry last updated
Jul 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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