Kronik Berilyum Hastalığında (CBD) Bağışıklık Yanıtının Epigenetik Düzenlenmesinde Maruziyet

Sade dilde özet

Bu gözlemsel çalışma, kronik berilyum hastalığında (chronic beryllium disease, CBD) berilyum maruziyetinin bağışıklık yanıtının epigenetik düzenlenmesindeki rolünü incelemektedir. Çalışmaya, berilyum maruziyeti ve ilgili test sonuçları olan kronik berilyum hastalığı ya da berilyum duyarlılığı bulunan kişiler ile maruziyeti olmayan sağlıklı kontroller katılabilmektedir. Çalışma faz uygulanmayan bir gözlem çalışması olarak yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

N/A

Durum

Tamamlandı

Sponsor

National Jewish Health

Müdahale

Nothing

Başlangıç

14.12.2014

Tahmini bitiş

31.12.2020

Ülkeler

United States

İlgili genler

Merkezler

• Denver, United States

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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 -