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Fibrosing ILD Biomarkers That Rule Acceleration

NCT05635032 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2023-10-27

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Centro Hospitalar De São João, E.P.E.

    collaborator OTHER

  • Instituto de Investigação e Inovação em Saúde (i3S)

    collaborator UNKNOWN

  • Fundação para a Ciência e a Tecnologia

    collaborator OTHER

  • Universidade do Porto

    lead OTHER

Principal Investigators

  • Helder Novais Bastos, MD, PhD · Universidade do Porto

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2024-02-29
Completion
2026-03-31

Countries

  • Portugal

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05635032 on ClinicalTrials.gov