Pulmonary FibrosisFIBROMETNCT06974799
Metabolomic Biomarkers Evaluation in Pulmonary Fibrosis
An observational study of Pulmonary Fibrosis, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Fibrosis
- What is being tested?
- Fatty acids measurement
- How many people
- 59 participants
- Where
- 1 siteItaly
- Study dates
- 5 May 2023to 18 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with a diagnosis of IPF or other fibrotising interstitial lung disease within 5 years
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Metabolomic Biomarkers 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
- Conditions
- Pulmonary Fibrosis
- Being tested
- Fatty acids measurement
- Keywords
- Metabolomic, Pulmonary Fibrosis
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatty acids measurementDiagnostic test
Serum analysis for metabolomic biomarker identification
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Fibrosis patients | Not described Receives: Diagnostic Test: Fatty acids measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatty acids measurement
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start5 May 2023
- Primary completion15 Jul 2024
- Study completion18 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Collaborators
- Ceinge - Biotecnologie Avanzate s.c. a r.l.
- Responsible party
- Principal investigator, Andrea Bianco, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974799
- Sponsor's protocol ID
- 7721
- Acronym
- FIBROMET
- Status last verified
- May 2025
- First submitted
- 25 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Metabolomic Biomarkers in Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT06974799
- Acronym / sponsor ID
- FIBROMET / 7721
- Conditions
- Pulmonary Fibrosis
- Keywords
- Metabolomic, Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Collaborators
- Ceinge - Biotecnologie Avanzate s.c. a r.l.
- Study start
- 5 May 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 18 Jan 2025 (actual)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Fibrosis patients | – | Diagnostic Test: Fatty acids measurement |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with a diagnosis of IPF or other fibrotising interstitial lung disease within 5 years
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fatty acids measurementSerum analysis for metabolomic biomarker identification | Diagnostic test | Pulmonary Fibrosis patients |
Primary outcome
Fatty acids measurement
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Fibrosis, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatty acids measurement (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.