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

January 29, 2026 updated by: Assistance Publique Hopitaux De Marseille
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Non-exposed
Subject with low exposure to silica <0.1 mg/m3 in the course of their professional activity
Other: Respiratory function testing
Spirometry, plethysmography, FeNO test
Biological: blood sampling
25mL peripheral blood will be collected
Other: Exposed
Subject with moderate or high exposure to silica (>= 0.1 mg/m3) in the course of their professional activity
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence ratio of AACD146 between the exposed and non-exposed groups.
Time Frame: At enrollment
At enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
AACD146 prevalence in patients with interstitial or neoplastic lung disease.
Time Frame: At enrollment
At enrollment
AACD146 Prevalence by type of interstitial lung disease
Time Frame: At enrollment
At enrollment
AACD146 Prevalence by type of histological type of lung cancer.
Time Frame: At enrollment
At enrollment
Correlation between AACD146 and exposure duration and dose to silica
Time Frame: At enrollment
At enrollment
Correlation between AACD146 and soluble CD146
Time Frame: At enrollment
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A02509-38

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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