Bio Metrology of Nonfibrous Mineral Particles in Bronchoalveolar Lavage Fluids

NCT ID: NCT03917485

Last Updated: 2023-09-06

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-05

Study Completion Date

2023-06-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Occupational Exposure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Intercommunal de Créteil

Créteil, , France

Site Status

Countries

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France

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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