Diagnostic Value of KL-6 in ILD

NCT ID: NCT03103191

Last Updated: 2020-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Case

* 50 subjects with fibrosing interstitial lung disease.
* 50 subjects with pulmonary fibrosis secondary to collagen diseases.

KL-6 levels

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Measure of KL-6 in serum

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

KL-6 levels

Measure of KL-6 in serum

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Claudia Erika Delgado Espinoza

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IIBSP-KLS-2016-39

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.