Occupational ExposureILDNCT04879082
Identification Of Occupational Exposures In Patients With ILD
An observational study of Occupational Exposure and Interstitial Lung Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Diffuse interstitial lung disease brings together a heterogeneous group of pulmonary pathologies, characterized by infiltrating and diffuse lesions of the pulmonary interstitium. The evolving risk of these ILD is pulmonary fibrosis, with the development of chronic respiratory failure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Occupational Exposure, Interstitial Lung Disease
- What is being tested?
- Professional course, occupational exposures
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2020to 15 Apr 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with ILD
Who may be able to join
- Patients with ILD.
- File discussed in a multidisciplinary meeting since May 2020 at the Louis Pradel Pneumological Hospital.
- Have benefited from a professional interview in the Occupational pathology consultation center of the Hospital Center Lyon Sud.
Who cannot join
- Patients with sarcoidosis.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de consultation de pathologie professionnelle, Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
About this study
Official title: Identification of Occupational Exposures in Patients With Interstitial Lung Diseases (ILD)
Diffuse interstitial lung disease brings together a heterogeneous group of pulmonary pathologies, characterized by infiltrating and diffuse lesions of the pulmonary interstitium. The evolving risk of these ILD is pulmonary fibrosis, with the development of chronic respiratory failure.
The process of the etiological diagnosis of ILD results from a multidisciplinary approach (pulmonologists, radiologists, occupational health specialists, anatomo-pathologists, etc…). Indeed, the multitude of possible causes of these diseases makes the etiological diagnosis difficult. Professional aetiologies are also frequently mentioned : pneumoconiosis, hypersensitivity pneumonitis, as a differential diagnosis.
Read more
It therefore appears essential to deepen the professional aspect during the diagnostic process for ILD.
Since May 2020, a professional interview has been systematically offered by the Occupational Pathology Consultation Center of the Hospital Center Lyon Sud, to patients followed by the team of Professor Vincent COTTIN, whose file was discussed in a multidisciplinary meeting.
The data collected to constitute a database are the following variables: age, sex, diploma, professional course coded in CITP (International Standard Classification of Professions) and NAF (French Nomenclature of Activities), occupational exposures, smoking, risk factors non-professionals, clinical elements of ILD and elements relating to an occupational disease certificate. This database is anonymized.
- Conditions
- Occupational Exposure, Interstitial Lung Disease
- Being tested
- Professional course, occupational exposures
- Keywords
- Occupational Exposure, Lung Fibrosis, Interstitial Lung Disease, Pulmonary Fibrosis
- Medical subject headings
- Lung Diseases, Interstitial, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Professional course, occupational exposuresOther
The data collected are the following variables: age, sex, diploma, professional course coded in CITP (International Standard Classification of Professions) and NAF (French Nomenclature of Activities), occupational exposures, smoking, risk factors non-professionals, clinical elements of ILD and elements relating to an occupational disease certificate. This database is anonymized.
The precise diagnosis of ILD is retained during the multidisiciplinary meeting.
Occupational exposures are assessed in specialized consultation :
- a first professional interview phase: The professional history is traced, listing the training courses followed and the trades carried out. The questioning is precise and focuses on the different tasks performed, and the products used.
- a second step, where a questionnaire is completed by the doctor: A list of specific substances is offered to the patient, who responds whether or not he thinks he has been exposed to them in his professional past.
| Study group | Role | What they receive |
|---|---|---|
| ILD | Patients with ILD, whose file has been discussed in a multidisciplinary meeting since May 2020 at the Louis Pradel Pneumological Hospital, and who have benefited from a professional interview in the Occupational pathology consultation center of the Hospital Center Lyon Sud. Receives: Other: Professional course, occupational exposures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the distribution of occupational exposures according to the types of ILD. The precise diagnosis is retained during the multidisiciplinary meeting.
Precise diagnosis of ILD : type of PID diagnosed
Measured: The precise diagnosis of ILD is retained immediately after the multidisiciplinary meeting.
Occupational exposures are assessed in specialized consultation by the occupational physician.
Occupational exposures
Measured: Occupational exposures are assessed immediately after the occupational consultation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start15 May 2020
- Primary completion15 Mar 2021
- Study completion15 Apr 2021
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.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879082
- Sponsor's protocol ID
- A257
- Acronym
- ILD
- Status last verified
- Mar 2021
- First submitted
- 26 Mar 2021
- Last updated
- 10 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Occupational Exposures in Patients With Interstitial Lung Diseases (ILD)
- ClinicalTrials.gov ID
- NCT04879082
- Acronym / sponsor ID
- ILD / A257
- Conditions
- Occupational Exposure, Interstitial Lung Disease
- Keywords
- Occupational Exposure, Lung Fibrosis, Interstitial Lung Disease, Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 10 May 2021 (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.
Diffuse interstitial lung disease brings together a heterogeneous group of pulmonary pathologies, characterized by infiltrating and diffuse lesions of the pulmonary interstitium. The evolving risk of these ILD is pulmonary fibrosis, with the development of chronic respiratory failure.
The process of the etiological diagnosis of ILD results from a multidisciplinary approach (pulmonologists, radiologists, occupational health specialists, anatomo-pathologists, etc…). Indeed, the multitude of possible causes of these diseases makes the etiological diagnosis difficult. Professional aetiologies are also frequently mentioned : pneumoconiosis, hypersensitivity pneumonitis, as a differential diagnosis.
It therefore appears essential to deepen the professional aspect during the diagnostic process for ILD.
Since May 2020, a professional interview has been systematically offered by the Occupational Pathology Consultation Center of the Hospital Center Lyon Sud, to patients followed by the team of Professor Vincent COTTIN, whose file was discussed in a multidisciplinary meeting.
The data collected to constitute a database are the following variables: age, sex, diploma, professional course coded in CITP (International Standard Classification of Professions) and NAF (French Nomenclature of Activities), occupational exposures, smoking, risk factors non-professionals, clinical elements of ILD and elements relating to an occupational disease certificate. This database is anonymized.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ILD | – | Other: Professional course, occupational exposuresPatients with ILD, whose file has been discussed in a multidisciplinary meeting since May 2020 at the Louis Pradel Pneumological Hospital, and who have benefited from a professional interview in the Occupational pathology consultation center of the Hospital Center Lyon Sud. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with ILD
Key inclusion criteria (3 listed)
- Patients with ILD.
- File discussed in a multidisciplinary meeting since May 2020 at the Louis Pradel Pneumological Hospital.
- Have benefited from a professional interview in the Occupational pathology consultation center of the Hospital Center Lyon Sud.
Key exclusion criteria (1 listed)
- Patients with sarcoidosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Professional course, occupational exposuresThe data collected are the following variables: age, sex, diploma, professional course coded in CITP (International Standard Classification of Professions) and NAF (French Nomenclature of Activities), occupational exposures, smoking, risk factors non-professionals, clinical elements of ILD and elements relating to an occupational disease certificate. This database is anonymized. The precise diagnosis of ILD is retained during the multidisiciplinary meeting. Occupational exposures are assessed in specialized consultation : * a first professional interview phase: The professional history is traced, listing the training courses followed and the trades carried out. The questioning is precise and focuses on the different tasks performed, and the products used. * a second step, where a questionnaire is completed by the doctor: A list of specific substances is offered to the patient, who responds whether or not he thinks he has been exposed to them in his professional past. | Other | ILD |
Primary outcome
Study the distribution of occupational exposures according to the types of ILD. The precise diagnosis is retained during the multidisiciplinary meeting.
Time frame: The precise diagnosis of ILD is retained immediately after the multidisiciplinary meeting.
Precise diagnosis of ILD : type of PID diagnosed
Occupational exposures are assessed in specialized consultation by the occupational physician.
Time frame: Occupational exposures are assessed immediately after the occupational consultation.
Occupational exposures
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 10 May 2021.
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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 and Interstitial Lung Disease, run by Hospices Civils de Lyon 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 3 inclusion and 1 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 10 May 2021. 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?
Study the distribution of occupational exposures according to the types of ILD. The precise diagnosis is retained during the multidisiciplinary meeting. (time frame: The precise diagnosis of ILD is retained immediately after the multidisiciplinary meeting.). The study lists 2 primary outcomes in all. 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 10 May 2021.