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NCT02596347 · ClinicalTrials.gov registry record
The Role of JAK2 in Alveolar Macrophages (AM's) in Chronic Beryllium Disease (CBD)
A clinical trial, sponsored by National Jewish Health.
- Completed
- Registry status
- 3
- Enrollment target
NCT02596347: Completed study, sponsored by National Jewish Health.
NCT02596347 is a clinical trial that has completed, run by National Jewish Health. The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02596347 has completed, sponsored by National Jewish Health.
- COMPLETED
- Registry status
- 3 participants
- Enrollment target
Study Summary
Current studies suggest that alveolar macrophages (AM) act as silencers of most immune responses in the lung. However, in pathological conditions, such as asthma, hypersensitivity pneumonitis, and sarcoidosis, AMs become involved in the maintenance and further expansion of the immune response in the target organ. The Investigator has preliminary data demonstrating that CBD AMs at the site of disease involvement (bronchoalveolar lavage, BAL) display an activated cell surface phenotype compared to AMs from healthy controls. Furthermore, exciting data from our group demonstrates significant differences in gene expression profiles between CBD and Beryllium Sensitivity (BeS) bronchial alveolar lavage (BAL) cells, in pivotal immune response genes and networks. Specifically, the Investigator has found the JAK/STAT pathway and the JAK2 gene was dramatically overexpressed in CBD BAL cells. In addition, constitutively phosphorylated JAK2 (pJAK2) was found in AMs from Chronic Beryllium Disease (CBD) patients by Westernblot and was increased after beryllium (Be) stimulation for 30 min. Moreover, the JAK2 inhibitor TG101348 significantly inhibited Be-induced CBD AMs TNFa and IFNy production. Meanwhile, overexpression of the JAK2 inhibitor SOCS 1 (suppressors of cytokine signaling) protein decreased Be-induced TNFa production from AMs. Based on this information, the Investigator hypothesizes that CBD AMs overexpress JAK2, which augments the immune response to Be and development of CBD but not BeS. The investigators believe that these studies are highly innovative since they will undoubtedly shed light on exposure-mediated immune dysregulation in Alveolar Macrophages (AMs) that lead to disease development and likely progression and with additional study of this pathway will reveal potential biomarkers for clinical prognosis and diagnosis. The results obtained from this study will improve the investigators understanding of factors involved in the development of Chronic Beryllium d
Primary Outcome
As the primary outcome is the downregulation of TNFalpha level with the inhibition of the JAK2 using the inhibitor TG101348 in CBD, we expect a 50% reduction with a standard deviation of 0.2 based on our preliminary data. We will have more than 95% power with n=6 CBD patients for these aims.
Interventions
- PROCEDURE Blood draw
- PROCEDURE bronchoscopy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2015-04 |
| Est. Completion | 2019-12-06 |
What the finished NCT02596347 record still lists
NCT02596347 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 3 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Blood draw is the first listed.
NCT02596347 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02596347 about?
NCT02596347 is a clinical study titled "The Role of JAK2 in Alveolar Macrophages (AM's) in Chronic Beryllium Disease (CBD)". Current studies suggest that alveolar macrophages (AM) act as silencers of most immune responses in the lung. However, in pathological conditions, such as asthma, hypersensitivity pneumonitis, and sarcoidosis, AMs become involved in the maintenance and further expansion of the immune response in the...
What is the current status of trial NCT02596347?
This trial is currently completed. The enrollment target is 3 participants. The study started on 2015-04. Estimated completion is 2019-12-06.
What interventions are being tested in trial NCT02596347?
The interventions under investigation include: Blood draw (PROCEDURE), bronchoscopy (PROCEDURE).
Who is sponsoring clinical trial NCT02596347?
This trial is sponsored by National Jewish Health, which has 83 total clinical trials registered on ClinicalTrials.gov.
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