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

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ClinicalTrials.gov Identifier: NCT03917485
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

Brief 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.


Condition or disease
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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bio Metrology of Nonfibrous Mineral Particles in Bronchoalveolar Lavage Fluids
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals




Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Broncho-Alveolar Washing Fluid


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917485


Contacts
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Contact: Jean-Claude Pairon +33157022090 jc.pairon@chicreteil.fr

Locations
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France
Centre Hospitalier Intercommunal de Créteil Recruiting
Créteil, France, 94010
Contact: Jean-Claude Pairon, Pr    157022093 ext 0033    JC.Pairon@chicreteil.fr   
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil

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Responsible Party: Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT03917485     History of Changes
Other Study ID Numbers: REACTIT
2018-A00475-50 ( Other Identifier: ID-RCB )
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No