Pulmonary SarcoidosisBERYSARCNCT06113991
Study Comparing Chronic Beryllium Disease to Pulmonary Sarcoidosis
An observational study of Pulmonary Sarcoidosis and Chronic Beryllium Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Inhalation of beryllium can induce specific sensitization and diffuse pulmonary granulomatosis called chronic beryllium disease (CBD). The clinical, radiographic, and anatomopathological features of CBD are very similar to those of sarcoidosis, another granulomatosis, making its diagnosis difficult. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Sarcoidosis, Chronic Beryllium Disease
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2023to 14 Dec 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
- No healthy volunteers
- Adult, Older adult
Study population: patients with chronic beryllium disease compared to pulmonary sarcoidosis
Who may be able to join
- Age ≥ 18 years
- Sufficiently documented medical record.
- Informed patients who did not object to participating in the research, or for deceased patients, did not object to the use of their data.
- Cases: Patients followed for confirmed chronic beryllium disease by expert teams based on the ATS 2014 criteria, i.e., a history of exposure to beryllium, positivity of two abnormal lymphocyte proliferation tests (LPT) in blood and/or an abnormal LPT in bronchoalveolar lavage, granuloma found in pulmonary biopsy associated by compatible clinical, radiological or spirometric abnormalities.
- Controls: Patients followed for sarcoidosis according to the ATS/ERS/WASOG criteria, i.e., (i) a compatible presentation, (ii) the presence of non-necrotizing granulomatosis in one or more tissues (except Löfgren's syndrome or Heerfordt syndrome), (iii) and exclusion of alternative causes of granulomatous diseases with pulmonary parenchymal involvement on thoracic CT and/or chest radiography.
- Controls: without occupational exposure to beryllium.
Who cannot join
- Patients under trustee.
Trial locations and contacts
1 site in 1 country.
Dominique VALEYRE, MD contact
France1 site, 1 recruiting
- Recruiting
001 - Service Pneumologie
Bobigny, Avicenne
About this study
Official title: Retrospective Multicenter Case-control Study Comparing Chronic Beryllium Disease to Pulmonary Sarcoidosis
Inhalation of beryllium can induce specific sensitization and diffuse pulmonary granulomatosis called chronic beryllium disease (CBD). The clinical, radiographic, and anatomopathological features of CBD are very similar to those of sarcoidosis, another granulomatosis, making its diagnosis difficult. In addition, the progression of CBD is poorly understood. The investigators hypothesis is that there are specific clinical, biological, anatomopathological, and radiological presentation specificities of CBD, as well as a worse prognosis compared to pulmonary sarcoidosis.
Read the detailed description
Inhalation of beryllium can induce specific sensitization and diffuse pulmonary granulomatosis called chronic beryllium disease (CBD). The clinical, radiographic, and anatomopathological features of CBD are very similar to those of sarcoidosis, another granulomatosis, making its diagnosis difficult. In addition, the progression of CBD is poorly understood . The investigators hypothesis is that there are specific clinical, biological, anatomopathological, and radiological presentation specificities of CBD, as well as a worse prognosis compared to pulmonary sarcoidosis.
- Conditions
- Pulmonary Sarcoidosis, Chronic Beryllium Disease
- Medical subject headings
- Sarcoidosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients without professional exposure to beryllium | Patients without professional exposure to beryllium | |
| Patients with chronic pulmonary berylliosis | Patients with chronic pulmonary berylliosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The phenotypic profile at inclusion will be based on clinical data
symptoms at diagnosis
Measured: baseline
The phenotypic profile at inclusion will be based on clinical data
general signs(number and type of organs affected)
Measured: baseline
The phenotypic profile at inclusion will be based on biological data
serum angiotensin-converting enzyme assay (hydrolysis of one micromole of substrate per minute)
Measured: baseline
The phenotypic profile at inclusion will be based on biological data
blood calcium(mmol/L)
Measured: baseline
The phenotypic profile at inclusion will be based on biological data
calciuria (mmol/kg/J)
Measured: baseline
The phenotypic profile at inclusion will be based on biological data
blood lymphocytes(mm3)
Measured: baseline
The phenotypic profile at inclusion will be based on biological data
gamma globulinemia (g/L)
Measured: baseline
The phenotypic profile at inclusion will be based on functional data
extra-functional explorations with measurement in absolute value and as a percentage of the theoretical value of total lung capacity (L)
Measured: baseline
The phenotypic profile at inclusion will be based on functional data
residual volume (%)
Measured: baseline
The phenotypic profile at inclusion will be based on functional data
forced vital capacity (L)
Measured: baseline
The phenotypic profile at inclusion will be based on functional data
maximum exhaled volume (L)
Measured: baseline
The phenotypic profile at inclusion will be based on functional data
Tiffeneau (%)
Measured: baseline
The phenotypic profile at inclusion will be based on functional data
carbon monoxide diffusion capacity (%)
Measured: baseline
The phenotypic profile at inclusion will be based on functional data
transfer coefficient (%)
Measured: baseline
The phenotypic profile at inclusion will be based on functional data
6-minute walk test (m)
Measured: baseline
The phenotypic profile at inclusion will be based on radiological data
extent and description on chest CT of elementary lesions activity lesions (mm)
Measured: baseline
The phenotypic profile at inclusion will be based on radiological data
fibrosis patterns (absence/presence)
Measured: baseline
The phenotypic profile at inclusion will be based on radiological data
signs of pulmonary hypertension (absence/presence)
Measured: baseline
Secondary outcomes (6)
Survival without transplantation
Survival without transplantation will be measured from the date of inclusion until death and/or lung transplantation, or the date of last follow-up.
Measured: From date of baseline until the date of death,or date of lung transplantation or date of last visit whichever came first
The occurrence of comorbidities and complications related to the disease and to treatment
The occurrence of comorbidities will correspond to the presence of comorbidities (smoking, alcoholism, obesity, diabetes, hypertension, other medical history)
Measured: baseline
Therapeutic management
Therapeutic management will be studied by immediate indication of treatment
Measured: baseline
Psycho-social consequences
Psycho-social consequences will be evaluated by the number of sick leaves, the existence of professional reclassification, and the number of hospitalizations
Measured: baseline and last visit in 2022
Respiratory functional evolution
Respiratory functional evolution will correspond to the absolute variation of the respiratory function parameters extra-functional explorations with measurement in absolute value and as a percentage of the theoretical value of total lung capacity, residual volume, forced vital capacity, maximum exhaled volume, Tiffeneau, carbon monoxide diffusion capacity, transfer coefficient, 6-minute walk test, PaO2, PaCO2
Measured: baseline and last visit in 2022
CT scan evolution
CT scan evolution will study the data from the latest available thoracic CT scan
Measured: last visit in 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start14 Jun 2023
- Primary completion14 Jun 2023
- Study completion14 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary SarcoidosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113991
- Sponsor's protocol ID
- APHP230386
- Acronym
- BERYSARC
- Status last verified
- May 2023
- First submitted
- 6 Jun 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Multicenter Case-control Study Comparing Chronic Beryllium Disease to Pulmonary Sarcoidosis
- ClinicalTrials.gov ID
- NCT06113991
- Acronym / sponsor ID
- BERYSARC / APHP230386
- Conditions
- Pulmonary Sarcoidosis, Chronic Beryllium Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 14 Dec 2023 (estimated)
- First posted
- 2 Nov 2023 (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.
Inhalation of beryllium can induce specific sensitization and diffuse pulmonary granulomatosis called chronic beryllium disease (CBD). The clinical, radiographic, and anatomopathological features of CBD are very similar to those of sarcoidosis, another granulomatosis, making its diagnosis difficult. In addition, the progression of CBD is poorly understood. The investigators hypothesis is that there are specific clinical, biological, anatomopathological, and radiological presentation specificities of CBD, as well as a worse prognosis compared to pulmonary sarcoidosis.
Detailed description
Inhalation of beryllium can induce specific sensitization and diffuse pulmonary granulomatosis called chronic beryllium disease (CBD). The clinical, radiographic, and anatomopathological features of CBD are very similar to those of sarcoidosis, another granulomatosis, making its diagnosis difficult. In addition, the progression of CBD is poorly understood . The investigators hypothesis is that there are specific clinical, biological, anatomopathological, and radiological presentation specificities of CBD, as well as a worse prognosis compared to pulmonary sarcoidosis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without professional exposure to beryllium | – | –Patients without professional exposure to beryllium |
| Patients with chronic pulmonary berylliosis | – | –Patients with chronic pulmonary berylliosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic beryllium disease compared to pulmonary sarcoidosis
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Sufficiently documented medical record.
- Informed patients who did not object to participating in the research, or for deceased patients, did not object to the use of their data.
- Cases: Patients followed for confirmed chronic beryllium disease by expert teams based on the ATS 2014 criteria, i.e., a history of exposure to beryllium, positivity of two abnormal lymphocyte proliferation tests (LPT) in blood and/or an abnormal LPT in bronchoalveolar lavage, granuloma found in pulmonary biopsy associated by compatible clinical, radiological or spirometric abnormalities.
- Controls: Patients followed for sarcoidosis according to the ATS/ERS/WASOG criteria, i.e., (i) a compatible presentation, (ii) the presence of non-necrotizing granulomatosis in one or more tissues (except Löfgren's syndrome or Heerfordt syndrome), (iii) and exclusion of alternative causes of granulomatous diseases with pulmonary parenchymal involvement on thoracic CT and/or chest radiography.
Key exclusion criteria (1 listed)
- Patients under trustee.
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
The phenotypic profile at inclusion will be based on clinical data
Time frame: baseline
symptoms at diagnosis
The phenotypic profile at inclusion will be based on clinical data
Time frame: baseline
general signs(number and type of organs affected)
The phenotypic profile at inclusion will be based on biological data
Time frame: baseline
serum angiotensin-converting enzyme assay (hydrolysis of one micromole of substrate per minute)
The phenotypic profile at inclusion will be based on biological data
Time frame: baseline
blood calcium(mmol/L)
The phenotypic profile at inclusion will be based on biological data
Time frame: baseline
calciuria (mmol/kg/J)
The phenotypic profile at inclusion will be based on biological data
Time frame: baseline
blood lymphocytes(mm3)
The phenotypic profile at inclusion will be based on biological data
Time frame: baseline
gamma globulinemia (g/L)
The phenotypic profile at inclusion will be based on functional data
Time frame: baseline
extra-functional explorations with measurement in absolute value and as a percentage of the theoretical value of total lung capacity (L)
The phenotypic profile at inclusion will be based on functional data
Time frame: baseline
residual volume (%)
The phenotypic profile at inclusion will be based on functional data
Time frame: baseline
forced vital capacity (L)
The phenotypic profile at inclusion will be based on functional data
Time frame: baseline
maximum exhaled volume (L)
The phenotypic profile at inclusion will be based on functional data
Time frame: baseline
Tiffeneau (%)
The phenotypic profile at inclusion will be based on functional data
Time frame: baseline
carbon monoxide diffusion capacity (%)
The phenotypic profile at inclusion will be based on functional data
Time frame: baseline
transfer coefficient (%)
The phenotypic profile at inclusion will be based on functional data
Time frame: baseline
6-minute walk test (m)
The phenotypic profile at inclusion will be based on radiological data
Time frame: baseline
extent and description on chest CT of elementary lesions activity lesions (mm)
The phenotypic profile at inclusion will be based on radiological data
Time frame: baseline
fibrosis patterns (absence/presence)
The phenotypic profile at inclusion will be based on radiological data
Time frame: baseline
signs of pulmonary hypertension (absence/presence)
6 secondary outcomes
Survival without transplantation
Time frame: From date of baseline until the date of death,or date of lung transplantation or date of last visit whichever came first
The occurrence of comorbidities and complications related to the disease and to treatment
Time frame: baseline
Therapeutic management
Time frame: baseline
Psycho-social consequences
Time frame: baseline and last visit in 2022
Respiratory functional evolution
Time frame: baseline and last visit in 2022
CT scan evolution
Time frame: last visit in 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
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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.
Dominique VALEYRE, MD contact
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 Pulmonary Sarcoidosis and Chronic Beryllium Disease, run by Assistance Publique - Hôpitaux de Paris 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 6 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: status not confirmed, as of the sponsor's last update on 2 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florence JENY, MD (+331.48.95.52.80, florence.jeny@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The phenotypic profile at inclusion will be based on clinical data (time frame: baseline). The study lists 18 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 2 Nov 2023.