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

NCT02197364 | Completed DMC

• 1 other identifier: KL-6_20140715
• Study Type: observational
• Target: 1,190
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Interstitial Lung Disease

Keywords

Interstitial Lung Disease; Diagnosis; Krebs Von Den Lungen-6

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• The KL-6 concentration on the immune analyzer

  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

  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

  pretherapy, 30-90 days after treatment

Study Arms (1)

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.

Eligibility Criteria

• Age: 14 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Serums from patients with cancer
• Serums with visible precipitate
• Serums with floc

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead
• Fujirebio Diagnostics, Inc.: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

The residual serums in the clinical laboratory.

MeSH Terms

Conditions

Lung Diseases, Interstitial; Disease; Medullary cystic kidney disease 1

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Li Hui Ping

  Shanghai Pulmonary Hospital , Tongji University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor,Chief of Dept. of Respiratory Medicine

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 22, 2014
• Study Start: December 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 22, 2014

Record last verified: 2014-07