Exploring the Immunology of Sarcoidosis

Completed

• Conditions: Sarcoidosis

• Registration Number: NCT04637165
• Lead Sponsor: Hull University Teaching Hospitals NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-11
• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-19
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. Males or females, of any race, between 18 and 85 years of age, inclusive
2. Able to provide written informed consent
3. Clinician diagnosis of sarcoidosis
4. Treatment-naïve or receiving immunomodulatory therapy.

Exclusion Criteria

1. Evidence of acute bacterial infection or other condition likely in the opinion of the investigator to significantly impact results of blood assays.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Castle Hill Hospital; 🇬🇧 Cottingham, East Yorkshire, United Kingdom