Study Comparing Chronic Beryllium Disease to Pulmonary Sarcoidosis

NCT06113991 | Unknown

• 1 other identifier: APHP230386
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Sarcoidosis; Chronic Beryllium Disease

Outcome Measures

Primary Outcomes (18)

• The phenotypic profile at inclusion will be based on clinical data

  symptoms at diagnosis

  baseline

• The phenotypic profile at inclusion will be based on clinical data

  general signs(number and type of organs affected)

  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)

  baseline

• The phenotypic profile at inclusion will be based on biological data

  blood calcium(mmol/L)

  baseline

• The phenotypic profile at inclusion will be based on biological data

  calciuria (mmol/kg/J)

  baseline

• The phenotypic profile at inclusion will be based on biological data

  blood lymphocytes(mm3)

  baseline

• The phenotypic profile at inclusion will be based on biological data

  gamma globulinemia (g/L)

  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)

  baseline

• The phenotypic profile at inclusion will be based on functional data

  residual volume (%)

  baseline

• The phenotypic profile at inclusion will be based on functional data

  forced vital capacity (L)

  baseline

• The phenotypic profile at inclusion will be based on functional data

  maximum exhaled volume (L)

  baseline

• The phenotypic profile at inclusion will be based on functional data

  Tiffeneau (%)

  baseline

• The phenotypic profile at inclusion will be based on functional data

  carbon monoxide diffusion capacity (%)

  baseline

• The phenotypic profile at inclusion will be based on functional data

  transfer coefficient (%)

  baseline

• The phenotypic profile at inclusion will be based on functional data

  6-minute walk test (m)

  baseline

• The phenotypic profile at inclusion will be based on radiological data

  extent and description on chest CT of elementary lesions activity lesions (mm)

  baseline

• The phenotypic profile at inclusion will be based on radiological data

  fibrosis patterns (absence/presence)

  baseline

• The phenotypic profile at inclusion will be based on radiological data

  signs of pulmonary hypertension (absence/presence)

  baseline

Secondary Outcomes (6)

• Survival without transplantation

  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

  baseline

• Therapeutic management

  baseline

• Psycho-social consequences

  baseline and last visit in 2022

• Respiratory functional evolution

  baseline and last visit in 2022

Study Arms (2)

Patients without professional exposure to beryllium

Patients without professional exposure to beryllium

Patients with chronic pulmonary berylliosis

Patients with chronic pulmonary berylliosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with chronic beryllium disease compared to pulmonary sarcoidosis

You may qualify if:

• 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: without occupational exposure to beryllium.

You may not qualify if:

• Patients under trustee.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

001 - Service Pneumologie

Bobigny, Avicenne, France

RECRUITING

MeSH Terms

Conditions

Sarcoidosis, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Sarcoidosis; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Central Study Contacts

Florence JENY, MD

CONTACT

+331.48.95.52.80; florence.jeny@aphp.fr

Dominique VALEYRE, MD

CONTACT

dominique.valeyre@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: November 2, 2023
• Study Start: June 14, 2023
• Primary Completion: June 14, 2023
• Study Completion: December 14, 2023
• Last Updated: November 2, 2023

Record last verified: 2023-05

Locations

FR (1)