Exploring the Immunology of Sarcoidosis

April 19, 2023 updated by: Hull University Teaching Hospitals NHS Trust
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • East Yorkshire
      • Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
        • Recruiting
        • Castle Hill Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with sarcoidosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years
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 years
Cytokines - blood
Time Frame: 3 years
Inflammatory mediator concentrations in unstimulated and stimulated blood samples.
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibodies - blood
Time Frame: 3 years
Exploratory description of immunogenic proteins identified by serological analysis of recombinant complementary deoxyribonucleic acid expression libraries.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hull University Teaching Hospitals NHS Trust

Collaborators

University of York

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2019

Primary Completion (Actual)

December 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

October 26, 2020

First Submitted That Met QC Criteria

November 18, 2020

First Posted (Actual)

November 19, 2020

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 19, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R2421

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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