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CompletedNCT03917485REACTITUpdated Sep 6, 2023

Bio Metrology of Nonfibrous Mineral Particles in Bronchoalveolar Lavage Fluids

An observational study in Occupational Exposure, sponsored by Centre Hospitalier Intercommunal Creteil. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-06.

Sponsored by Centre Hospitalier Intercommunal Creteil · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
105
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Occupational Exposure
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In context

Lead sponsor

Centre Hospitalier Intercommunal Creteil is the lead sponsor of 131 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Subjects not exposed to Non-fibrous Mineral Particle in a professional and / or environmental way

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
105 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 1 month

Secondary outcomes

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

    Identification of particles

    Time frame: 1 month

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

    seize of particles

    Time frame: 1 month

07

Study locations

1 site
  • Centre Hospitalier Intercommunal de Créteil
    Créteil, 94010, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03917485
Lead sponsor
Centre Hospitalier Intercommunal Creteil
Responsible party
Sponsor
First posted
Apr 17, 2019
Start date
Dec 5, 2018
Primary completion
Jun 2, 2023
Completion
Jun 2, 2023
Last update
Sep 6, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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