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OpenTrials
Completed

NCT Number: NCT06974799

Metabolomic Biomarkers Evaluation in Pulmonary Fibrosis

Pulmonary fibrosis (PF) are a heterogeneous group of interstitial lung diseases who may have a progressive phenotype often associated with loss of lung function, chronic respiratory symptoms, quality of life limitation as well significant morbidity and mortality. The identification of reliable biomarkers able to help in early diagnosis and predict disease progression are crucial for improving patient life. Although many biomarkers have been proposed, there is no consensus on reliable markers for IPF. Alterations in fatty acid (FA) metabolism have drawn increasing attention in the IPF pathogenesis, but there is no consensus on the specific FA changes. Alterations in FA composition have been shown to promote pro-fibrotic traits in epithelial cells, fibroblasts, and myofibroblasts. However, while specific fatty acid (FA) alterations have been identified in the serum of IPF patients, no consensus exists on the exact changes for individual FAs

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UOC Clinica Pneumologica L Vanvitelli

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed IPF diagnosis based on the 2018 ATS/ERS/JRS/ALAT guidelines [PMID: 30168753] or other fibrotising ILDs within the past five years,
  • Age ≥ 40 years, 3) ability to provide informed consent.

Exclusion criteria

  • A current diagnosis of asthma or chronic obstructive pulmonary disease (COPD), 2) an acute PF exacerbation within the past three months.
  • Use of medications who may alter metabolomic biomarkers, ex. statins.

Treatment and study plan

Fatty acids measurement

Diagnostic Test

Serum analysis for metabolomic biomarker identification

Primary outcomes

  1. Fatty acids measurement

    Time frame: six months

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Collaborators

  • Ceinge - Biotecnologie Avanzate s.c. a r.l.

Registry information

Official study title

Evaluation of Metabolomic Biomarkers in Pulmonary Fibrosis

Acronym: FIBROMET

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
May 16, 2025
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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