Metabolomic Biomarkers Evaluation in Pulmonary Fibrosis

NCT ID: NCT06974799

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-05

Study Completion Date

2025-01-18

Brief Summary

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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

Detailed Description

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Conditions

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Pulmonary Fibrosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pulmonary Fibrosis patients

Fatty acids measurement

Intervention Type DIAGNOSTIC_TEST

Serum analysis for metabolomic biomarker identification

Interventions

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Fatty acids measurement

Serum analysis for metabolomic biomarker identification

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

UNKNOWN

Sponsor Role collaborator

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Andrea Bianco

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UOC Clinica Pneumologica L Vanvitelli

Naples, , Italy

Site Status

Countries

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Italy

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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7721

Identifier Type: -

Identifier Source: org_study_id

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