Exploring the Immunology of Sarcoidosis
Study Details
Study Description
Brief Summary
In sarcoidosis, over activity of parts of the immune system drives the accumulation of granulomas (collections of immune cells) in affected parts of the body. To facilitate development of effective and safe treatment options in the future it will be vital to understand how and why the immune system becomes over active. The aim of this research is to work towards this goal by studying cells of the immune system and the molecular pathways inside these cells that control how they behave. This will be achieved by analysing patterns of proteins and RNA (the code used to tell cells which proteins to produce) in immune cells present in blood samples and tissue biopsies from people with sarcoidosis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Transcriptomics (RNA) -tissue [3 years]
RNA expression and distribution (on different cell types) will be scored quantitatively or semi-quantitatively. Statistical analysis will be descriptive with heat maps for RNA expression (clustered using complete-linkage clustering) and charts (median and interquartile ranges) for comparisons.
Secondary Outcome Measures
- Protein - tissue [3 years]
Expression and distribution (on different cell types) of proteins which will be scored quantitatively or semi-quantitatively. Results will be descriptive. Comparisons will be made using appropriate statistical techniques.
- Transcriptomics (RNA) - blood [3 years]
RNA expression in unstimulated and stimulated blood samples using Nanostring transcriptomics. Statistical analysis will be descriptive with heat maps for RNA and protein expression (clustered using complete-linkage clustering) and charts (median and interquartile ranges) for comparisons.
- Cytokines - blood [3 years]
Inflammatory mediator concentrations in unstimulated and stimulated blood samples.
Other Outcome Measures
- Antibodies - blood [3 years]
Exploratory description of immunogenic proteins identified by serological analysis of recombinant complementary deoxyribonucleic acid expression libraries.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Males or females, of any race, between 18 and 85 years of age, inclusive
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Able to provide written informed consent
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Clinician diagnosis of sarcoidosis
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Treatment-naïve or receiving immunomodulatory therapy.
Exclusion Criteria:
- Evidence of acute bacterial infection or other condition likely in the opinion of the investigator to significantly impact results of blood assays.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Castle Hill Hospital | Cottingham | East Yorkshire | United Kingdom | HU16 5JQ |
Sponsors and Collaborators
- Hull University Teaching Hospitals NHS Trust
- University of York
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R2421