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Exploring the Immunology of Sarcoidosis

Exploring the Immunology of Sarcoidosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04637165
Enrollment
9
Registered
2020-11-19
Start date
2019-11-11
Completion date
2023-12-31
Last updated
2024-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoidosis

Keywords

macrophage, lymphocyte, cytokine, immunology

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.

Interventions

This is a non-interventional study

Sponsors

University of York
CollaboratorOTHER
Hull University Teaching Hospitals NHS Trust
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Transcriptomics (RNA) -tissue3 yearsRNA 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

MeasureTime frameDescription
Protein - tissue3 yearsExpression 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) - blood3 yearsRNA 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 - blood3 yearsInflammatory mediator concentrations in unstimulated and stimulated blood samples.

Other

MeasureTime frameDescription
Antibodies - blood3 yearsExploratory description of immunogenic proteins identified by serological analysis of recombinant complementary deoxyribonucleic acid expression libraries.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026