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NCT03103191 Clinical Trial

Diagnostic Value of KL-6 in ILD

Pulmonary Fibrosis Clinical Trial

Official title:
Diagnostic Value of KL-6 in Interstitial Lung Diseases

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03103191
Other study ID # IIBSP-KLS-2016-39
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 2016
Est. completion date December 2023

Study information
Verified date August 2020
Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

KL-6 may be a useful biomarker in patients with interstitial lung disease, but there is limited information in non-Asian populations. Therefore, it is necessary to carry out studies in other populations to confirm the diagnostic values of the biomarker and its prognostic implication.

Hypothesis KL-6 may be a useful biomarker in the management of interstitial lung diseases. But it is necessary to know more about its utility in the European population.

Study Objectives:

- To determine the concentration of KL-6 in serum of patients with pulmonary fibrosis at the time of diagnosis compared to patients without pulmonary fibrosis

- Diagnostic yield of KL-6 in patients with pulmonary fibrosis.

- Correlation of KL-6 values with functional and radiological parameters of disease severity at diagnosis.

- Correlation of serum KL-6 values with the evolution of the disease.

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date December 2023
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Subjects older than 18 years.

2. Chronic respiratory diseases )including Fibrotic interstitial lung disease, asthma or COPD) related or not to a connective tissue disease.

3. Acceptance of the patient to participate in the study by signing the informed consent after having discussed with the researchers the objectives, risks and potential benefits.

Exclusion Criteria:

1. Absence of informed consent

2. Psychiatric disorder or limitation of collaboration (including language, socio-cultural problem, etc.).

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• KL-6 levels
Measure of KL-6 in serum

Locations
Country Name City State
Spain Hospital de la Santa Creu i Sant Pau Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum KL-6 levels in patients with pulmonary fibrosis at the time of diagnosis. Baseline
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