Pulmonary FibrosisNCT03103191
Diagnostic Value of KL-6 in ILD
An observational study of Pulmonary Fibrosis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Fibrosis
- What is being tested?
- KL-6 levels
- How many people
- 250 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2016to Dec 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects over 18 years of age attending the outpatient clinic at Hospital de la Santa Creu i Sant Pau.
Who may be able to join
- 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.
Who cannot join
- Absence of informed consent
- Psychiatric disorder or limitation of collaboration (including language, socio-cultural problem, etc.).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Claudia Erika Delgado Espinoza, CDelgadoE@santpau.cat
Diego Castillo, PhD
About this study
Official title: Diagnostic Value of KL-6 in Interstitial Lung Diseases
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.
Read more
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.
- Conditions
- Pulmonary Fibrosis
- Being tested
- KL-6 levels
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KL-6 levelsDiagnostic test
Measure of KL-6 in serum
| Study group | Role | What they receive |
|---|---|---|
| Case | * 50 subjects with fibrosing interstitial lung disease.
* 50 subjects with pulmonary fibrosis secondary to collagen diseases. Receives: Diagnostic Test: KL-6 levels | |
| 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. Receives: Diagnostic Test: KL-6 levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum KL-6 levels in patients with pulmonary fibrosis at the time of diagnosis.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study startJun 2016
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103191
- Sponsor's protocol ID
- IIBSP-KLS-2016-39
- Status last verified
- Aug 2020
- First submitted
- 23 Mar 2017
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of KL-6 in Interstitial Lung Diseases
- ClinicalTrials.gov ID
- NCT03103191
- Acronym / sponsor ID
- IIBSP-KLS-2016-39
- Conditions
- Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Diagnostic Test: KL-6 levels* 50 subjects with fibrosing interstitial lung disease. * 50 subjects with pulmonary fibrosis secondary to collagen diseases. |
| Control | – | Diagnostic Test: KL-6 levels* 75 subjects without pulmonary fibrosis but with other common respiratory diseases like asthma, COPD or bronchiectasis. * 75 subjects with collagen disease without pulmonary fibrosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects over 18 years of age attending the outpatient clinic at Hospital de la Santa Creu i Sant Pau.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Absence of informed consent
- Psychiatric disorder or limitation of collaboration (including language, socio-cultural problem, etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KL-6 levelsMeasure of KL-6 in serum | Diagnostic test | Case, Control |
Primary outcome
Serum KL-6 levels in patients with pulmonary fibrosis at the time of diagnosis.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Fibrosis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum KL-6 levels in patients with pulmonary fibrosis at the time of diagnosis. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.