Occupational ExposureREACTITNCT03917485
Bio Metrology of Nonfibrous Mineral Particles in Bronchoalveolar Lavage Fluids
An observational study of Occupational Exposure, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occupational Exposure
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2018to 2 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects not exposed to Non-fibrous Mineral Particle in a professional and / or environmental way
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Occupational Exposure
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (2)
Name of non fibrous mineral particles in LBA (Bronchoalveolar lavage) (nombre of particules by ml)
Identification of particles
Measured: 1 month
seize of non fibrous mineral particles in LBA (Bronchoalveolar lavage)
seize of particles
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start5 Dec 2018
- Primary completion2 Jun 2023
- Study completion2 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917485
- Sponsor's protocol ID
- REACTIT
- Other IDs
- 2018-A00475-50
- Acronym
- REACTIT
- Status last verified
- Sep 2023
- First submitted
- 4 Apr 2019
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio Metrology of Nonfibrous Mineral Particles in Bronchoalveolar Lavage Fluids
- ClinicalTrials.gov ID
- NCT03917485
- Acronym / sponsor ID
- REACTIT / REACTIT
- Conditions
- Occupational Exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 2 Jun 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects not exposed to Non-fibrous Mineral Particle in a professional and / or environmental way
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Name of non fibrous mineral particles in LBA (Bronchoalveolar lavage) (nombre of particules by ml)
Time frame: 1 month
seize of non fibrous mineral particles in LBA (Bronchoalveolar lavage)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occupational Exposure, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of non fibrous mineral particles in LBA (Bronchoalveolar lavage) (nombre of particles by ml) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.