Study Comparing Chronic Beryllium Disease to Pulmonary Sarcoidosis (BERYSARC)

October 27, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
    • Avicenne
      • Bobigny, Avicenne, France
        • Recruiting
        • 001 - Service Pneumologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with chronic beryllium disease compared to pulmonary sarcoidosis

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients without professional exposure to beryllium
Patients with chronic pulmonary berylliosis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The phenotypic profile at inclusion will be based on clinical data
Time Frame: baseline
symptoms at diagnosis
baseline
The phenotypic profile at inclusion will be based on clinical data
Time Frame: baseline
general signs(number and type of organs affected)
baseline
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)
baseline
The phenotypic profile at inclusion will be based on biological data
Time Frame: baseline
blood calcium(mmol/L)
baseline
The phenotypic profile at inclusion will be based on biological data
Time Frame: baseline
calciuria (mmol/kg/J)
baseline
The phenotypic profile at inclusion will be based on biological data
Time Frame: baseline
blood lymphocytes(mm3)
baseline
The phenotypic profile at inclusion will be based on biological data
Time Frame: baseline
gamma globulinemia (g/L)
baseline
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)
baseline
The phenotypic profile at inclusion will be based on functional data
Time Frame: baseline
residual volume (%)
baseline
The phenotypic profile at inclusion will be based on functional data
Time Frame: baseline
forced vital capacity (L)
baseline
The phenotypic profile at inclusion will be based on functional data
Time Frame: baseline
maximum exhaled volume (L)
baseline
The phenotypic profile at inclusion will be based on functional data
Time Frame: baseline
Tiffeneau (%)
baseline
The phenotypic profile at inclusion will be based on functional data
Time Frame: baseline
carbon monoxide diffusion capacity (%)
baseline
The phenotypic profile at inclusion will be based on functional data
Time Frame: baseline
transfer coefficient (%)
baseline
The phenotypic profile at inclusion will be based on functional data
Time Frame: baseline
6-minute walk test (m)
baseline
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)
baseline
The phenotypic profile at inclusion will be based on radiological data
Time Frame: baseline
fibrosis patterns (absence/presence)
baseline
The phenotypic profile at inclusion will be based on radiological data
Time Frame: baseline
signs of pulmonary hypertension (absence/presence)
baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Survival without transplantation will be measured from the date of inclusion until death and/or lung transplantation, or the date of last follow-up.
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
The occurrence of comorbidities will correspond to the presence of comorbidities (smoking, alcoholism, obesity, diabetes, hypertension, other medical history)
baseline
Therapeutic management
Time Frame: baseline
Therapeutic management will be studied by immediate indication of treatment
baseline
Psycho-social consequences
Time Frame: baseline and last visit in 2022
Psycho-social consequences will be evaluated by the number of sick leaves, the existence of professional reclassification, and the number of hospitalizations
baseline and last visit in 2022
Respiratory functional evolution
Time Frame: baseline and last visit in 2022
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
baseline and last visit in 2022
CT scan evolution
Time Frame: last visit in 2022
CT scan evolution will study the data from the latest available thoracic CT scan
last visit in 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 14, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP230386

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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