Exposure in Epigenetic Regulation of Immune Response in Chronic Beryllium Disease (CBD)

Plain-language summary

This observational study examines the role of beryllium exposure in the epigenetic regulation of the immune response in chronic beryllium disease (CBD). People with chronic beryllium disease or beryllium sensitization who have beryllium exposure and relevant test results, as well as unexposed healthy controls, may take part. It was carried out as an observational study with no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

National Jewish Health

Intervention

Nothing

Start date

12/14/2014

Estimated completion

12/31/2020

Countries

United States

Related genes

Locations

• Denver, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

Chronic Beryllium Disease (CBD):

1. History of Beryllium exposure
2. Positive blood and/or bronchoalveolar lavage (BAL) Beryllium Lymphocyte Proliferation Tests (BeLPT)
3. Biopsy-proven pathologic changes consistent with CBD, specifically non-caseating granulomas and/or mononuclear cell interstitial infiltrates.

Beryllium Sensitization:

1. History of Beryllium exposure
2. Two or more positive blood beryllium lymphocyte proliferation tests (BeLPT) or positive bronchoalveolar lavage (BAL) BeLPT
3. Normal lung tissue (no histology suggestive of CBD).

Normal Controls:

1. No history of beryllium exposure
2. Former smokers or never smokers -

Exclusion Criteria:

Chronic Beryllium Disease:

1. Immunosuppressive therapy within the last three months
2. Current cigarette smoking or smoking within six months prior to the study
3. Positive lung washing or biopsy cultures for fungi, mycobacteria or other respiratory pathogen consistent with an acute or chronic infection
4. Weight less than 110 lbs. (for venipuncture)
5. Pregnancy
6. Severe room air hypoxemia and or hypercapnia (precluding BAL), e.g., resting PaO2 \< 45, PaCO2 \> 45 mm Hg; (Denver altitude 5,280 feet)
7. Presence of another disease that may be expected to significantly affect patient mortality and or the immune response (e.g., HIV, HCV, cancer, uncorrected bleeding diathesis, acute hypercapnia with a resting PaCO2 above 45 mm Hg; serious cardiac arrhythmia, recent myocardial infarction within 6 weeks)
8. Patient inability to participate in the study, such as inability to undergo venipuncture and BAL procedures that form part of the inclusion/exclusion criteria or part of the outcome measure

Beryllium Sensitization:

1. Known underlying systemic or lung disease;
2. Current cigarette smoking or smoking within six months prior to the study
3. Positive lung pathology consistent with CBD
4. Pregnancy
5. Weight less than 110 lbs. (for venipuncture)
6. Presence of another disease that may be expected to significantly affect patient mortality and or the immune response (e.g., HIV, HCV, cancer, uncorrected bleeding diathesis, serious cardiac arrhythmia; recent myocardial infarction within 6 weeks)
7. Patient inability to participate in the study, such as inability to undergo venipuncture and BAL procedures that form part of the inclusion/exclusion criteria or part of the outcome measure

Normal Controls:

1. History of beryllium exposure
2. Known underlying systemic or lung disease;
3. Immunosuppressive therapy or other medication for as systemic disease process in the last 3 months;
4. Current smokers or smoking within 6 months of study
5. Pregnancy
6. Weight less than 110 lbs. (for venipuncture)
7. Inability to undergo BAL or venipuncture procedures -