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

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.

Study Overview

• Status: Completed
• Conditions: Occupational Exposure

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.

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

• Study Contact: Name: Jean-Claude Pairon; Phone Number: +33157022090; Email: jc.pairon@chicreteil.fr

Study Locations

• France
  • Créteil, France, 94010
    • Centre Hospitalier Intercommunal de Créteil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Name of non fibrous mineral particles in LBA (Bronchoalveolar lavage) (nombre of particules by ml)	Identification of particles	1 month
seize of non fibrous mineral particles in LBA (Bronchoalveolar lavage)	seize of particles	1 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2018
• Primary Completion (Actual): June 2, 2023
• Study Completion (Actual): June 2, 2023

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 17, 2019

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: REACTIT; 2018-A00475-50 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No