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OpenTrials
Completed

NCT Number: NCT04637165

Exploring the Immunology of Sarcoidosis

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.

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Key information

Conditions

Sarcoidosis Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lymphatic Diseases Lymphoproliferative Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Castle Hill Hospital

Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females, of any race, between 18 and 85 years of age, inclusive
  • Able to provide written informed consent
  • Clinician diagnosis of sarcoidosis
  • 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.

Treatment and study plan

This is a non-interventional study

Other

This is a non-interventional study

Primary outcomes

  1. Transcriptomics (RNA) -tissue

    Time frame: 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 outcomes

  1. Protein - tissue

    Time frame: 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.

  2. Transcriptomics (RNA) - blood

    Time frame: 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.

  3. Cytokines - blood

    Time frame: 3 years

    Inflammatory mediator concentrations in unstimulated and stimulated blood samples.

Other outcomes

  1. Antibodies - blood

    Time frame: 3 years

    Exploratory description of immunogenic proteins identified by serological analysis of recombinant complementary deoxyribonucleic acid expression libraries.

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Collaborators

  • University of York

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Nov 19, 2020
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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