Exposure OccupationalCD146-SILICENCT07376291
Use of Anti-CD146 Autoantibodies for the Diagnosis of Pulmonary Diseases Secondary to Occupational Exposure to Silica
A study testing Respiratory function testing, blood sampling and CT scan in people with Exposure Occupational and Pulmonary Diseases, run by Assistance Publique Hopitaux De Marseille.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exposure Occupational, Pulmonary Diseases
- What is being tested?
- Respiratory function testing, blood sampling and CT scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- Exposure Occupational, Pulmonary Diseases
- Being tested
- Respiratory function testing, blood sampling, CT scan
- Keywords
- silica, Exposure occupational, Pulmonary diseases
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory function testingOther
Spirometry, plethysmography, FeNO test
blood samplingBiological
25mL peripheral blood will be collected
CT scanRadiation
Non-injected thoracic CT scan
| Study group | Role | What they receive |
|---|---|---|
| Non-exposed | Other | Subject with low exposure to silica <0.1 mg/m3 in the course of their professional activity Receives: Other: Respiratory function testing; Biological: blood sampling |
| Exposed | Other | Subject with moderate or high exposure to silica (>= 0.1 mg/m3) in the course of their professional activity Receives: Other: Respiratory function testing; Biological: blood sampling; Radiation: CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence ratio of AACD146 between the exposed and non-exposed groups.
Measured: At enrollment
Secondary outcomes (5)
AACD146 prevalence in patients with interstitial or neoplastic lung disease.
Measured: At enrollment
AACD146 Prevalence by type of interstitial lung disease
Measured: At enrollment
AACD146 Prevalence by type of histological type of lung cancer.
Measured: At enrollment
Correlation between AACD146 and exposure duration and dose to silica
Measured: At enrollment
Correlation between AACD146 and soluble CD146
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exposure OccupationalStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376291
- Sponsor's protocol ID
- 2024-A02509-38
- Acronym
- CD146-SILICE
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Anti-CD146 Autoantibodies for the Diagnosis of Pulmonary Diseases Secondary to Occupational Exposure to Silica
- ClinicalTrials.gov ID
- NCT07376291
- Acronym / sponsor ID
- CD146-SILICE / 2024-A02509-38
- Conditions
- Exposure Occupational, Pulmonary Diseases
- Keywords
- silica, Exposure occupational, Pulmonary diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-exposed | Other | Other: Respiratory function testing, Biological: blood samplingSubject with low exposure to silica <0.1 mg/m3 in the course of their professional activity |
| Exposed | Other | Other: Respiratory function testing, Biological: blood sampling, Radiation: CT scanSubject with moderate or high exposure to silica (>= 0.1 mg/m3) in the course of their professional activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Subject, male or female, aged 18 or over
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory function testingSpirometry, plethysmography, FeNO test | Other | Exposed, Non-exposed |
| blood sampling25mL peripheral blood will be collected | Biological | Exposed, Non-exposed |
| CT scanNon-injected thoracic CT scan | Radiation | Exposed |
Primary outcome
Prevalence ratio of AACD146 between the exposed and non-exposed groups.
Time frame: At enrollment
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory function testing, blood sampling and CT scan in people with Exposure Occupational and Pulmonary Diseases, run by Assistance Publique Hopitaux De Marseille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence ratio of AACD146 between the exposed and non-exposed groups. (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.