About this trial
This prospective, multicenter study aims to evaluate the relevance of anti-CD146 autoantibodies (AACD146) as biological markers for the early diagnosis of pulmonary diseases related to occupational exposure to silica. Silica exposure is a recognized risk factor for fibrotic, inflammatory, and cancerous respiratory diseases. Currently, no specific biological marker exists. The hypothesis is that AACD146 reflects early effects of silica exposure. The study will include 110 participants divided into two groups (exposed vs. non-exposed) and will compare AACD146 prevalence according to exposure level and the presence of respiratory diseases.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject, male or female, aged 18 or over
Subject with low exposure to silica <0.1 mg/m3 in the course of their professional activity, quantified during an occupational health consultation using an employment-exposure matrix
Subjects capable of consenting to participate in the study by signing a written informed consent form
Subjects who are beneficiaries of or affiliated with a social security system
Disqualifiers
Minor subject
Subject refusing to undergo the examinations required by the protocol
Contraindications to respiratory function tests: Recent eye or throat surgery, recent myocardial infarction or pulmonary embolism, poorly controlled high blood pressure, recent pneumothorax.
Pregnant or breastfeeding women, patients under guardianship or curatorship, deprived of liberty
Trial design
Parallel
Treatments tested in this trial
Respiratory function testing
Other interventionSpirometry, plethysmography, FeNO test
blood sampling
Biological/Vaccine25mL peripheral blood will be collected
CT scan
RadiationNon-injected thoracic CT scan
Treatment groups
Trial outcomes
Primary outcomes
Prevalence ratio of AACD146 between the exposed and non-exposed groups.
Secondary outcomes
AACD146 prevalence in patients with interstitial or neoplastic lung disease.
AACD146 Prevalence by type of interstitial lung disease
AACD146 Prevalence by type of histological type of lung cancer.
Correlation between AACD146 and exposure duration and dose to silica
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: