Fibrosing ILD Biomarkers That Rule Acceleration

Sarcoidosis Clinical Trial

— FIBRALUNG  

Official title:

Host-microbiome Interactions in the Quest for Fibrosing ILD Biomarkers That Rule Acceleration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05635032
• Other study ID #: FIBRALUNG
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: March 31, 2026

Study information

• Verified date: November 2022
• Source: Universidade do Porto
• Contact: Helder Novais Bastos, MD, PhD
• Phone: (+351) 220408800
• Email: hnovaisbastos[@]med.up.pt
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 31, 2026
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Fibrosis
• Sarcoidosis

Intervention

Other:
• Comprehensive clinical assessment and biological samples collection
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.

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Universitário São João	Porto

Sponsors (5)

Lead Sponsor	Collaborator
Universidade do Porto	Centro Hospitalar Universitário de São João, E.P.E., Faculty of Medicine (FMUP), Fundação para a Ciência e a Tecnologia, Instituto de Investigação e Inovação em Saúde (i3S)

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Variation in Computed Tomography Lung Densitometry		36 months
Other	Proportion of patients varying FVC ?5% predicted within 1 year of follow-up		36 months
Other	Proportion of patients varying DLCO ?10% predicted within 1 year of follow-up		36 months
Other	Time to progression or exacerbation		36 months
Other	Survival		36 months
Primary	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.	36 months
Secondary	Change in microbiome profile in progressive pulmonary fibrosis	To assess the impact of microbiome features in clinical progression and higher risk of acute exacerbation	24 months

External Links

•   Project presentation website