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Not yet recruiting NCT07376291

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

No phase Interventional Exposure Occupational Pulmonary Diseases

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: Respiratory function testing, blood sampling, CT scan.
Who it may be relevant to
Registry conditions: Exposure Occupational, Pulmonary Diseases. Basic parameters: from 18 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
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Other Respiratory function testing
    Spirometry, plethysmography, FeNO test
  • Biological blood sampling
    25mL peripheral blood will be collected
  • Radiation CT scan
    Non-injected thoracic CT scan

Primary outcome measures

  • Prevalence ratio of AACD146 between the exposed and non-exposed groups. [Time frame: At enrollment]
Secondary outcome measures (5)
  • AACD146 prevalence in patients with interstitial or neoplastic lung disease. [Time frame: At enrollment]
  • AACD146 Prevalence by type of interstitial lung disease [Time frame: At enrollment]
  • AACD146 Prevalence by type of histological type of lung cancer. [Time frame: At enrollment]
  • Correlation between AACD146 and exposure duration and dose to silica [Time frame: At enrollment]
  • Correlation between AACD146 and soluble CD146 [Time frame: At enrollment]

Eligibility 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

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

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07376291 · 2024-A02509-38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗