Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
250 participants
OBSERVATIONAL
2016-06-30
2023-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Case
* 50 subjects with fibrosing interstitial lung disease.
* 50 subjects with pulmonary fibrosis secondary to collagen diseases.
KL-6 levels
Measure of KL-6 in serum
Control
* 75 subjects without pulmonary fibrosis but with other common respiratory diseases like asthma, COPD or bronchiectasis.
* 75 subjects with collagen disease without pulmonary fibrosis.
KL-6 levels
Measure of KL-6 in serum
Interventions
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KL-6 levels
Measure of KL-6 in serum
Eligibility Criteria
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Inclusion Criteria
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
2. Psychiatric disorder or limitation of collaboration (including language, socio-cultural problem, etc.).
18 Years
ALL
No
Sponsors
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Locations
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Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Countries
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Facility Contacts
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Other Identifiers
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IIBSP-KLS-2016-39
Identifier Type: -
Identifier Source: org_study_id
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