Metabolomic Biomarkers Evaluation in Pulmonary Fibrosis

NCT06974799 | Completed

• 1 other identifier: 7721
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Fibrosis

Keywords

Metabolomic; Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Fatty acids measurement

  six months

Study Arms (1)

Pulmonary Fibrosis patients

Diagnostic Test: Fatty acids measurement

Interventions

Fatty acids measurement DIAGNOSTIC_TEST

Serum analysis for metabolomic biomarker identification

Pulmonary Fibrosis patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with a diagnosis of IPF or other fibrotising interstitial lung disease within 5 years

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead
• Ceinge - Biotecnologie Avanzate s.c. a r.l.: collaborator

Study Sites (1)

UOC Clinica Pneumologica L Vanvitelli

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 16, 2025
• Study Start: May 5, 2023
• Primary Completion: July 15, 2024
• Study Completion: January 18, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

IT (1)