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Not yet recruiting NCT07592637

Lung Disease and FLNA Mutations

No phase Interventional Emphysema

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiation: Chest HRCT.
Who it may be relevant to
Registry conditions: Emphysema. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prevalence and Characteristics of Lung Disease Associated With FLNA Mutations: a Multicenter Cross-sectional Study

Overview

Some sparse scientific data support the hypothesis that otherwise unexplained emphysema may be associated with FLNA variants. This transversal multicentric study aimed to describe the frequency of emphysema in patients carrying an FLNA variation. Patients with FLNA variations who accept the study will benefit from a chest physician's clinical examination, respiratory function tests, a cardiac ultrasound and a chest scan. The primary endpoint is to describe emphysema's frequency in patients carrying FLNA variation. The other objectives are to describe emphysema's features in these patients, the prevalence of pulmonary hypertension and to describe their lung function abnormalities. The final goal is to confirm the association between unexplained emphysema and FLNA mutation.

Interventions

  • Diagnostic test Radiation: Chest HRCT
    1. Radiation: Chest HRCT A chest HRCT to identify emphysema 2. Genetic: blood analysis If emphysema is identified, a blood analysis will be performed to exclude known causes of emphysema (Alpha-1 antitrypsin deficiency) NTproBNP for all patients 3. Lung function tests Lung function tests will be performed in accordance with ATS/ERS technical standard 4. Cardiac ultrasound

Primary outcome measures

  • Frequency of emphysema in patients carrying FLNA mutation [Time frame: 6 months +/- 2 weeks]
Secondary outcome measures (7)
  • Morphological of emphysema [Time frame: 6 months +/- 2 weeks]
  • Topographical characteristics of emphysema [Time frame: 6 months +/- 2 weeks]
  • Severity of emphysema [Time frame: 6 months +/- 2 weeks]
  • Probabilistic diagnosis of pulmonary hypertension [Time frame: 6 months +/- 2 weeks]
  • Prevalence of pulmonary hypertension [Time frame: 6 months +/- 2 weeks]
  • Descriptive analysis of functional respiratory abnormalities measured by the functional respiratory test [Time frame: 6 months +/- 2 weeks]
  • Frequency of unexplained emphysema in patients carrying a FLNA mutation [Time frame: 6 months +/- 2 weeks]

Eligibility criteria

Inclusion criteria

  • Patient with an FLNA mutation (or gene alteration)
  • Patient who has given written consent to participate in the trial
  • Socially insured patient
  • Patient willing to comply with all study procedures and duration

Exclusion criteria

  • Patient refused or unable to give informed consent
  • Administrative reasons: inability to receive information, inability to participate in the entire study, lack of coverage by the social security system,
  • Pregnant or breastfeeding women
  • Patient under guardianship
  • Persons deprived of liberty

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • Lille University Hospital — Lille

Identifiers

NCT: NCT07592637 · 2025_0283

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗