Exposure Occupational, Pulmonary Diseases
Conditions
Keywords
silica, Exposure occupational, Pulmonary diseases
Brief summary
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.
Interventions
OTHERRespiratory function testing
Spirometry, plethysmography, FeNO test
BIOLOGICALblood sampling
25mL peripheral blood will be collected
RADIATIONCT scan
Non-injected thoracic CT scan
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for non-exposed group: * 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 Inclusion Criteria for exposed group: * Subject, male or female, aged 18 or over * Subject with moderate or high 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
Exclusion criteria
for each group: * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence ratio of AACD146 between the exposed and non-exposed groups. | At enrollment |
Secondary
| Measure | Time frame |
|---|---|
| AACD146 prevalence in patients with interstitial or neoplastic lung disease. | At enrollment |
| AACD146 Prevalence by type of interstitial lung disease | At enrollment |
| AACD146 Prevalence by type of histological type of lung cancer. | At enrollment |
| Correlation between AACD146 and exposure duration and dose to silica | At enrollment |
| Correlation between AACD146 and soluble CD146 | At enrollment |
Outcome results
None listed