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OpenTrials
Completed

NCT Number: NCT03917485

Bio Metrology of Nonfibrous Mineral Particles in Bronchoalveolar Lavage Fluids

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Intercommunal de Créteil

Créteil, 94010, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of non fibrous mineral particles in LBA (Bronchoalveolar lavage) (nombre of particles by ml)

    Time frame: 1 month

    Quantitative analysis of Non Fibrous Mineral Particles on samples obtained from subjects selected free from any significant occupational or environmental exposure to Non-fibrous Mineral Particle.

Secondary outcomes

  1. Name of non fibrous mineral particles in LBA (Bronchoalveolar lavage) (nombre of particules by ml)

    Time frame: 1 month

    Identification of particles

  2. seize of non fibrous mineral particles in LBA (Bronchoalveolar lavage)

    Time frame: 1 month

    seize of particles

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Acronym: REACTIT

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Apr 17, 2019
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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