Fibrosing ILD Biomarkers That Rule Acceleration

Recruiting

• Conditions: Pulmonary Fibrosis; Sarcoidosis
• Interventions: Other: Comprehensive clinical assessment and biological samples collection

• Registration Number: NCT05635032
• Lead Sponsor: Universidade do Porto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Status Verified: 2022-11
• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2022-11-22
• Study First Posted: 2022-12-02
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-27
• Primary Completion: 2024-02-29
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Progressive Pulmonary Fibrosis (non-IPF)	Comprehensive clinical assessment and biological samples collection	Patients with non-IPF interstitial lung diseases, presenting a progressive fibrosing phenotype, or acute exacerbations.
IPF	Comprehensive clinical assessment and biological samples collection	Patients with Idiophatic Pulmonary Fibrosis (IPF), serving as a prototype of a progressive fibroproliferative disorder.
Non-Progressive Pulmonary Fibrosis (non-IPF)	Comprehensive clinical assessment and biological samples collection	Patients with fibrotic non-IPF interstitial lung diseases that are stable during a minimum follow-up of 24 months.

Primary Outcome Measures

Name	Time	Method
Discover biomarkers in progressive pulmonary fibrosis	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.

Secondary Outcome Measures

Name	Time	Method
Change in microbiome profile in progressive pulmonary fibrosis	24 months	To assess the impact of microbiome features in clinical progression and higher risk of acute exacerbation

Trial Locations

Locations (1)

Centro Hospitalar Universitário São João; 🇵🇹 Porto, Portugal