Use of Anti-CD146 Autoantibodies for the Diagnosis of Pulmonary Diseases Secondary to Occupational Exposure to Silica (CD146-SILICE)

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Begins enrollment in 3 months

Conditions: Exposure Occupational; Pulmonary Diseases

Treatments: Biological: blood sampling; Other: Respiratory function testing; Radiation: CT scan

Study type: Interventional

Funder types: Other

Identifiers

NCT07376291

2024-A02509-38

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Non-exposed

Other group

Description:

Subject with low exposure to silica \<0.1 mg/m3 in the course of their professional activity

Treatment:

Other: Respiratory function testing

Biological: blood sampling

Exposed

Other group

Description:

Subject with moderate or high exposure to silica (\>= 0.1 mg/m3) in the course of their professional activity

Treatment:

Radiation: CT scan

Other: Respiratory function testing

Biological: blood sampling