Pulmonary FibrosisFIBRALUNGNCT05635032
Fibrosing ILD Biomarkers That Rule Acceleration
An observational study of Pulmonary Fibrosis and Sarcoidosis, run by Universidade do Porto at 1 site in Portugal.
Trial summary
FIBRALUNG is a prospective cohort study with biobank of samples from patients with pulmonary fibrosis, aiming to explore the molecular determinants of different clinical outcomes, acute exacerbations and mortality. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Fibrosis, Sarcoidosis
- What is being tested?
- Comprehensive clinical assessment and biological samples collection
- How many people
- 150 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Mar 2021to 31 Mar 2026
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from the Interstitial Lung Diseases unit of Centro Hospitalar Universitário de São João (Porto, Portugal).
Who may be able to join
- Patients aged between 18-80 years
- People undergoing blood collection, lung biopsy and/or BAL as part of their diagnostic workup
- Willingness to undergo the follow-up protocol evaluations
- Treatment-naïve for disease-modifying drugs
- An HRCT scan performed within the last 12 months showing ≥10% fibrosis extent of the lungs
Who cannot join
- People who cannot give informed consent
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Centro Hospitalar Universitário São João
Porto
Helder Novais Bastos, hnovaisbastos@med.up.pt
Rita Santos
About this study
Official title: Host-microbiome Interactions in the Quest for Fibrosing ILD Biomarkers That Rule Acceleration
FIBRALUNG is a prospective cohort study with biobank of samples from patients with pulmonary fibrosis, aiming to explore the molecular determinants of different clinical outcomes, acute exacerbations and mortality. We expect to gain deeper insight into fibroproliferative common pathways, particularly between idiopathic pulmonary fibrosis and fibrotic hypersensitivity pneumonitis, paving the way for new biomarkers that reflect the progressive phenotype, that eventually will support new targeted therapies.
Other idiopathic interstitial pneumonias, connective tissue disease-related interstitial lung diseases and sarcoidosis patients will be also recruited and their biological samples stored for further analyses.
- Conditions
- Pulmonary Fibrosis, Sarcoidosis
- Being tested
- Comprehensive clinical assessment and biological samples collection
- Medical subject headings
- Pulmonary Fibrosis, Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive clinical assessment and biological samples collectionOther
To establish the first Portuguese registry and biobank of PF-ILDs, comprising both extensive patient-level data, and systematic biological sampling (DNA, RNA, plasma, serum, bronchoalveolar lavage, lung tissue) at baseline and repeated biological sampling of blood and pharyngeal swabs performed at 6, 12 and 18 months, or whenever progression criteria are met or an acute exacerbation occurs. Participants will have regular visits at maximum intervals of 6 months, when their clinical condition and lung function tests are reassessed. A high resolution computed tomography (HRCT) scan of the lung will be performed every 12 months. Progressive fibrosis will be diagnosed based on meeting at least two of the following three criteria, occurring within the last year: (i) worsening of symptoms; (ii) absolute decline in FVC ≥5% predicted or absolute decline in DLCO (corrected for Hb) ≥10% predicted; (iii) increased extent of fibrotic changes on HRCT.
| Study group | Role | What they receive |
|---|---|---|
| IPF | Patients with Idiophatic Pulmonary Fibrosis (IPF), serving as a prototype of a progressive fibroproliferative disorder. Receives: Other: Comprehensive clinical assessment and biological samples collection | |
| Progressive Pulmonary Fibrosis (non-IPF) | Patients with non-IPF interstitial lung diseases, presenting a progressive fibrosing phenotype, or acute exacerbations. Receives: Other: Comprehensive clinical assessment and biological samples collection | |
| Non-Progressive Pulmonary Fibrosis (non-IPF) | Patients with fibrotic non-IPF interstitial lung diseases that are stable during a minimum follow-up of 24 months. Receives: Other: Comprehensive clinical assessment and biological samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discover biomarkers in progressive pulmonary fibrosis
Characterization of blood and tissue transcriptional signatures of progression and acute exacerbations, and validate findings at the protein expression level, which could be easily converted for clinical use as biomarkers.
Measured: 36 months
Secondary outcomes (1)
Change in microbiome profile in progressive pulmonary fibrosis
To assess the impact of microbiome features in clinical progression and higher risk of acute exacerbation
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start1 Mar 2021
- Primary completion29 Feb 2024 (estimated)
- Study completion31 Mar 2026 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar De São João, E.P.E., Instituto de Investigação e Inovação em Saúde (i3S), Fundação para a Ciência e a Tecnologia
- Responsible party
- Sponsor
- Investigators
- Helder Novais Bastos, MD, PhD, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635032
- Sponsor's protocol ID
- FIBRALUNG
- Acronym
- FIBRALUNG
- Status last verified
- Nov 2022
- First submitted
- 22 Nov 2022
- Last updated
- 27 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Host-microbiome Interactions in the Quest for Fibrosing ILD Biomarkers That Rule Acceleration
- ClinicalTrials.gov ID
- NCT05635032
- Acronym / sponsor ID
- FIBRALUNG / FIBRALUNG
- Conditions
- Pulmonary Fibrosis, Sarcoidosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Centro Hospitalar De São João, E.P.E., Instituto de Investigação e Inovação em Saúde (i3S), Fundação para a Ciência e a Tecnologia
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 2 Dec 2022 (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.
FIBRALUNG is a prospective cohort study with biobank of samples from patients with pulmonary fibrosis, aiming to explore the molecular determinants of different clinical outcomes, acute exacerbations and mortality. We expect to gain deeper insight into fibroproliferative common pathways, particularly between idiopathic pulmonary fibrosis and fibrotic hypersensitivity pneumonitis, paving the way for new biomarkers that reflect the progressive phenotype, that eventually will support new targeted therapies.
Other idiopathic interstitial pneumonias, connective tissue disease-related interstitial lung diseases and sarcoidosis patients will be also recruited and their biological samples stored for further analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IPF | – | Other: Comprehensive clinical assessment and biological samples collectionPatients with Idiophatic Pulmonary Fibrosis (IPF), serving as a prototype of a progressive fibroproliferative disorder. |
| Progressive Pulmonary Fibrosis (non-IPF) | – | Other: Comprehensive clinical assessment and biological samples collectionPatients with non-IPF interstitial lung diseases, presenting a progressive fibrosing phenotype, or acute exacerbations. |
| Non-Progressive Pulmonary Fibrosis (non-IPF) | – | Other: Comprehensive clinical assessment and biological samples collectionPatients with fibrotic non-IPF interstitial lung diseases that are stable during a minimum follow-up of 24 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the Interstitial Lung Diseases unit of Centro Hospitalar Universitário de São João (Porto, Portugal).
Key inclusion criteria (5 listed)
- Patients aged between 18-80 years
- People undergoing blood collection, lung biopsy and/or BAL as part of their diagnostic workup
- Willingness to undergo the follow-up protocol evaluations
- Treatment-naïve for disease-modifying drugs
- An HRCT scan performed within the last 12 months showing ≥10% fibrosis extent of the lungs
Key exclusion criteria (2 listed)
- People who cannot give informed consent
- Pregnancy
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 |
|---|---|---|
| Comprehensive clinical assessment and biological samples collectionTo establish the first Portuguese registry and biobank of PF-ILDs, comprising both extensive patient-level data, and systematic biological sampling (DNA, RNA, plasma, serum, bronchoalveolar lavage, lung tissue) at baseline and repeated biological sampling of blood and pharyngeal swabs performed at 6, 12 and 18 months, or whenever progression criteria are met or an acute exacerbation occurs. Participants will have regular visits at maximum intervals of 6 months, when their clinical condition and lung function tests are reassessed. A high resolution computed tomography (HRCT) scan of the lung will be performed every 12 months. Progressive fibrosis will be diagnosed based on meeting at least two of the following three criteria, occurring within the last year: (i) worsening of symptoms; (ii) absolute decline in FVC ≥5% predicted or absolute decline in DLCO (corrected for Hb) ≥10% predicted; (iii) increased extent of fibrotic changes on HRCT. | Other | IPF, Non-Progressive Pulmonary Fibrosis (non-IPF), Progressive Pulmonary Fibrosis (non-IPF) |
Primary outcome
Discover biomarkers in progressive pulmonary fibrosis
Time frame: 36 months
Characterization of blood and tissue transcriptional signatures of progression and acute exacerbations, and validate findings at the protein expression level, which could be easily converted for clinical use as biomarkers.
1 secondary outcome
Change in microbiome profile in progressive pulmonary fibrosis
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Project presentation websiteLink provided by the sponsor.
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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.
Helder Novais Bastos, MD, PhD principal investigator
Universidade do Porto
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 and Sarcoidosis, run by Universidade do Porto at 1 site in Portugal.
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 5 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 27 Oct 2023. 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 Portugal. 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?
Contact Helder Novais Bastos, MD, PhD ((+351) 220408800, hnovaisbastos@med.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discover biomarkers in progressive pulmonary fibrosis (time frame: 36 months). 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 27 Oct 2023.