Bio Metrology of Nonfibrous Mineral Particles in Bronchoalveolar Lavage Fluids
NCT ID: NCT03917485
Last Updated: 2023-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
105 participants
OBSERVATIONAL
2018-12-05
2023-06-02
Brief Summary
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This study will provide reference values for the interpretation and diagnosis of the cause of certain respiratory diseases potentially related to mineral particles.
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Detailed Description
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The bio metrology of these particles, namely their quantification in a biological medium requires reference values. These are essential for clinicians to interpret pulmonary retention in patients who may have been exposed professionally or environmentally to non-fibrous mineral particles.
A comparative study conducted in 2015 by lafp showed an increase in the particulate load of nonfibrous mineral particles, including titanium, in lung parenchyma samples over time.
Bronchoalveolar lavage fluid is typically considered to be representative of the lung for the analysis of nonfibrous mineral particles. The thresholds currently used for the bio metrology of nonfibrous mineral particles in bronchoalveolar lavage fluid samples are based on reference values established more than 20 years ago. It is therefore appropriate to update these reference values by establishing a new control population from the analysis of bronchoalveolar lavage fluid from subjects not exposed to the non-fibrous mineral particles in a professional or environmental manner.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Smokers and non-smokers (or weaners who have been weaned for at least 5 years).
* Acceptance to participate in the protocol.
* Affiliated to a social security scheme.
Exclusion Criteria
* Suspicion of pulmonary sarcoidosis ≥ stage 2, pneumoconiosis.
* Subjects with cystic fibrosis.
* Subjects chronic obstructive pulmonary disease (COPD) stage ≥ 3.
* Presence of serious comorbidities that are life-threatening in the short term.
* Refusal to participate in the study.
18 Years
ALL
Yes
Sponsors
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Centre Hospitalier Intercommunal Creteil
OTHER
Responsible Party
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Locations
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Centre Hospitalier Intercommunal de Créteil
Créteil, , France
Countries
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Other Identifiers
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2018-A00475-50
Identifier Type: OTHER
Identifier Source: secondary_id
REACTIT
Identifier Type: -
Identifier Source: org_study_id
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