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Diagnostic Value of KL-6 in ILD

Diagnostic Value of KL-6 in Interstitial Lung Diseases

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03103191
Enrollment
250
Registered
2017-04-06
Start date
2016-06-30
Completion date
2023-12-31
Last updated
2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Fibrosis

Brief 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.

Interventions

DIAGNOSTIC_TESTKL-6 levels

Measure of KL-6 in serum

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.).

Design outcomes

Primary

MeasureTime frame
Serum KL-6 levels in patients with pulmonary fibrosis at the time of diagnosis.Baseline

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026