Clinical trial NCT02197364: The Role of KL-6 in the Clinical Diagnosis of ILD
Official title: The Role of KL-6 as a Serum Biomarker in the Clinical Diagnosis of Interstitial Lung Diseases (ILD) in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Lung Disease
Keywords: Interstitial Lung Disease
Diagnosis
Krebs Von Den Lungen-6
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
Collaborators: name: Fujirebio Diagnostics, Inc.
First posted: 2014-07-22
Enrollment: 1190
Sex: ALL
Minimum age (years): 14
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The serums from clinical laboratory of Shanghai Pulmonary Hospital, Nanjing Drum Tower Hospital and Beijing Chaoyang Hospital.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The KL-6 concentration on the immune analyzer
timeFrame: The serum from patients with ILD will be collected for the duration of hospital stay, an average of 4 weeks
Secondary outcomes:
measure: The KL-6 concentration on the immune analyzer
timeFrame: The serum from patients other respiratory diseases will be collected for the duration of hospital stay, an average of 4 weeks
measure: The KL-6 concentration on the immune analyzer
timeFrame: The serum from healthy people will be collected for the duration of physical examination, an average of 1 day
measure: Change of KL-6 concentration on the immune analyzer
timeFrame: pretherapy, 30-90 days after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Pulmonary Hospital , Tongji University
name: Li Hui Ping
role: PRINCIPAL_INVESTIGATOR
References: