Clinical trial NCT06113991: Study Comparing Chronic Beryllium Disease to Pulmonary Sarcoidosis
Official title: Retrospective Multicenter Case-control Study Comparing Chronic Beryllium Disease to Pulmonary Sarcoidosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Sarcoidosis
Chronic Beryllium Disease
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with chronic beryllium disease compared to pulmonary sarcoidosis

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients under trustee.

Primary outcomes:
measure: The phenotypic profile at inclusion will be based on clinical data
timeFrame: baseline
measure: The phenotypic profile at inclusion will be based on clinical data
timeFrame: baseline
measure: The phenotypic profile at inclusion will be based on biological data
timeFrame: baseline
measure: The phenotypic profile at inclusion will be based on biological data
timeFrame: baseline
measure: The phenotypic profile at inclusion will be based on biological data
timeFrame: baseline
measure: The phenotypic profile at inclusion will be based on biological data
timeFrame: baseline
measure: The phenotypic profile at inclusion will be based on biological data
timeFrame: baseline
measure: The phenotypic profile at inclusion will be based on functional data
timeFrame: baseline
measure: The phenotypic profile at inclusion will be based on functional data
timeFrame: baseline
measure: The phenotypic profile at inclusion will be based on functional data
timeFrame: baseline
measure: The phenotypic profile at inclusion will be based on functional data
timeFrame: baseline
measure: The phenotypic profile at inclusion will be based on functional data
timeFrame: baseline
measure: The phenotypic profile at inclusion will be based on functional data
timeFrame: baseline
measure: The phenotypic profile at inclusion will be based on functional data
timeFrame: baseline
measure: The phenotypic profile at inclusion will be based on functional data
timeFrame: baseline
measure: The phenotypic profile at inclusion will be based on radiological data
timeFrame: baseline
measure: The phenotypic profile at inclusion will be based on radiological data
timeFrame: baseline
measure: The phenotypic profile at inclusion will be based on radiological data
timeFrame: baseline
Secondary outcomes:
measure: Survival without transplantation
timeFrame: From date of baseline until the date of death,or date of lung transplantation or date of last visit whichever came first
measure: The occurrence of comorbidities and complications related to the disease and to treatment
timeFrame: baseline
measure: Therapeutic management
timeFrame: baseline
measure: Psycho-social consequences
timeFrame: baseline and last visit in 2022
measure: Respiratory functional evolution
timeFrame: baseline and last visit in 2022
measure: CT scan evolution
timeFrame: last visit in 2022
Other outcomes:
Locations:
city: Bobigny
country: France
facility: 001 - Service Pneumologie
state: Avicenne
Study officials:
References: