Bio Metrology of Nonfibrous Mineral Particles in Bronchoalveolar Lavage Fluids (REACTIT)

  • STATUS
    Recruiting
  • End date
    Jul 5, 2023
  • participants needed
    100
  • sponsor
    Centre Hospitalier Intercommunal Creteil
Updated on 19 June 2022
Accepts healthy volunteers

Summary

The main purpose of this study is to update the pulmonary retention values of non-fibrous mineral particles in the general population.

This study will provide reference values for the interpretation and diagnosis of the cause of certain respiratory diseases potentially related to mineral particles.

Description

Some non-fibrous mineral particles are responsible for respiratory or systemic diseases, most often of occupational origin. Their use concerns multiple professional sectors.

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.

Details
Condition Occupational Exposure
Clinical Study IdentifierNCT03917485
SponsorCentre Hospitalier Intercommunal Creteil
Last Modified on19 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects not exposed to Non-fibrous Mineral Particle in a professional and / or environmental way
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 fibrosing pulmonary pathologies
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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