Exploring the Immunology of Sarcoidosis

Sarcoidosis Clinical Trial

Official title:

Exploring the Immunology of Sarcoidosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04637165
• Other study ID #: R2421
• Status: Recruiting
• Start date: November 11, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Hull University Teaching Hospitals NHS Trust
• Contact: Simon P Hart, PhD
• Phone: +44 1482 624067
• Email: s.hart[@]hull.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sarcoidosis

Intervention

Other:
• This is a non-interventional study
This is a non-interventional study

Locations

Country	Name	City	State
United Kingdom	Castle Hill Hospital	Cottingham	East Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Hull University Teaching Hospitals NHS Trust	University of York

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Antibodies - blood	Exploratory description of immunogenic proteins identified by serological analysis of recombinant complementary deoxyribonucleic acid expression libraries.	3 years
Primary	Transcriptomics (RNA) -tissue	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.	3 years
Secondary	Protein - tissue	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.	3 years
Secondary	Transcriptomics (RNA) - blood	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.	3 years
Secondary	Cytokines - blood	Inflammatory mediator concentrations in unstimulated and stimulated blood samples.	3 years