Diagnostic Value of KL-6 in ILD
Diagnostic Value of KL-6 in Interstitial Lung Diseases
1 other identifier
observational
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 23, 2017
CompletedFirst Posted
Study publicly available on registry
April 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedAugust 18, 2020
August 1, 2020
6.5 years
March 23, 2017
August 16, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Serum KL-6 levels in patients with pulmonary fibrosis at the time of diagnosis.
Baseline
Study Arms (2)
Case
* 50 subjects with fibrosing interstitial lung disease. * 50 subjects with pulmonary fibrosis secondary to collagen diseases.
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.
Interventions
Eligibility Criteria
Subjects over 18 years of age attending the outpatient clinic at Hospital de la Santa Creu i Sant Pau.
You may qualify if:
- Subjects older than 18 years.
- Chronic respiratory diseases )including Fibrotic interstitial lung disease, asthma or COPD) related or not to a connective tissue disease.
- 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.
You may not qualify if:
- Absence of informed consent
- Psychiatric disorder or limitation of collaboration (including language, socio-cultural problem, etc.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2017
First Posted
April 6, 2017
Study Start
June 1, 2016
Primary Completion
December 1, 2022
Study Completion
December 1, 2023
Last Updated
August 18, 2020
Record last verified: 2020-08