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NCT Number: NCT07376291

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Respiratory function testing

Other

Spirometry, plethysmography, FeNO test

Blood sampling

Biological

25mL peripheral blood will be collected

CT Scan

Radiation

Non-injected thoracic CT scan

Primary outcomes

  1. Prevalence ratio of AACD146 between the exposed and non-exposed groups.

    Time frame: At enrollment

Secondary outcomes

  1. AACD146 prevalence in patients with interstitial or neoplastic lung disease.

    Time frame: At enrollment

  2. AACD146 Prevalence by type of interstitial lung disease

    Time frame: At enrollment

  3. AACD146 Prevalence by type of histological type of lung cancer.

    Time frame: At enrollment

  4. Correlation between AACD146 and exposure duration and dose to silica

    Time frame: At enrollment

  5. Correlation between AACD146 and soluble CD146

    Time frame: At enrollment

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: CD146-SILICE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 29, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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