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NCT02604693 · ClinicalTrials.gov registry record
Exposure in Epigenetic Regulation of Immune Response in Chronic Beryllium Disease (CBD)
A clinical trial, sponsored by National Jewish Health.
- Completed
- Registry status
- 148
- Enrollment target
NCT02604693: Completed study, sponsored by National Jewish Health.
NCT02604693 is a clinical trial that has completed, run by National Jewish Health. The registered enrollment target is 148 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02604693 has completed, sponsored by National Jewish Health.
- COMPLETED
- Registry status
- 148 participants
- Enrollment target
Study Summary
This study will provide important results for each aim, while also providing an integrative transcriptional and epigenomic profile of CBD. In Aim 1 the Investigator will define genome-wide epigenetic alterations of CBD, by determining genes that are DM in pivotal immune cells, in the target organ (CD4+ BAL cells) in CBD compared to BeS and healthy controls. In addition, the Investigator will determine the impact of Be exposure on the methylation profile of CBD and BeS cells compared to each other and normal controls. This information will be used to define DM regions, genes and their networks. Using the cases and controls from Aim 1, we will evaluate the gene-expression from these same subjects in Aim 2 to define functional epigenetic loci based on DE in CD4+ BAL cells with and without Be exposure. The Investigator will also integrate ENCODE/RE methylation, histone modification, and chromatin accessibility data as well as our genome-wide association study (GWAS) data to prioritize epigenetic marks and networks for confirmation and validation in Aim 3. In Aim 3, the Investigator will test the generalizability of their findings, explore the potential of methylation marks as biomarkers of disease in PBMCs and determine if change in methylation of these targets with AZA or folic acid affects key immune and regulatory pathways in a second set of CBD and BeS subjects. Throughout the Aims, the Investigator will use both fresh CD4+ T cells to directly assess disease relevance and Be-stimulated cultured CD4+ T cells (compared to unstimulated cultured T cells) to assess the impact of environmental exposure .
Primary Outcome
The Investigators goal is to define an epigenomic profile for BeS and CBD and for Be exposure in the lung. Most studies using similar methods have demonstrated significant hypo- and hyper-methylation, in disease states, which we also expect to find. In addition, we expect to confirm an association between CBD and Th1 epigenetic regulation, finding DM in regions such as FOXP3, Th1 differentiation pathways and TNFalpha, likely with modulation of these and other regions with Be exposure. There is n
Interventions
- OTHER Nothing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2014-12-14 |
| Est. Completion | 2020-12-31 |
What the finished NCT02604693 record still lists
NCT02604693 is an observational study that tracks outcomes without assigning an intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Nothing is the first listed.
NCT02604693 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02604693 about?
NCT02604693 is a clinical study titled "Exposure in Epigenetic Regulation of Immune Response in Chronic Beryllium Disease (CBD)". This study will provide important results for each aim, while also providing an integrative transcriptional and epigenomic profile of CBD. In Aim 1 the Investigator will define genome-wide epigenetic alterations of CBD, by determining genes that are DM in pivotal immune cells, in the target organ (...
What is the current status of trial NCT02604693?
This trial is currently completed. The enrollment target is 148 participants. The study started on 2014-12-14. Estimated completion is 2020-12-31.
What interventions are being tested in trial NCT02604693?
The interventions under investigation include: Nothing (OTHER).
Who is sponsoring clinical trial NCT02604693?
This trial is sponsored by National Jewish Health, which has 83 total clinical trials registered on ClinicalTrials.gov.
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