- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05635032
Fibrosing ILD Biomarkers That Rule Acceleration (FIBRALUNG)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Helder Novais Bastos, MD, PhD
- Phone Number: (+351) 220408800
- Email: hnovaisbastos@med.up.pt
Study Contact Backup
- Name: Janete Santos, PhD
- Phone Number: (+351) 225 513 600
- Email: investigaclinica@med.up.pt
Study Locations
-
-
-
Porto, Portugal
- Recruiting
- Centro Hospitalar Universitario Sao Joao
-
Contact:
- Helder Novais Bastos
- Email: hnovaisbastos@med.up.pt
-
Sub-Investigator:
- Rita Santos
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- People who cannot give informed consent
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
IPF
Patients with Idiophatic Pulmonary Fibrosis (IPF), serving as a prototype of a progressive fibroproliferative disorder.
|
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.
|
Progressive Pulmonary Fibrosis (non-IPF)
Patients with non-IPF interstitial lung diseases, presenting a progressive fibrosing phenotype, or acute exacerbations.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in microbiome profile in progressive pulmonary fibrosis
Time Frame: 24 months
|
To assess the impact of microbiome features in clinical progression and higher risk of acute exacerbation
|
24 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Variation in Computed Tomography Lung Densitometry
Time Frame: 36 months
|
36 months
|
Proportion of patients varying FVC ⩾5% predicted within 1 year of follow-up
Time Frame: 36 months
|
36 months
|
Proportion of patients varying DLCO ⩾10% predicted within 1 year of follow-up
Time Frame: 36 months
|
36 months
|
Time to progression or exacerbation
Time Frame: 36 months
|
36 months
|
Survival
Time Frame: 36 months
|
36 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Helder Novais Bastos, MD, PhD, Faculty of Medicine (FMUP)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FIBRALUNG
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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