Exploring the Immunology of Sarcoidosis
1 other identifier
observational
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 11, 2019
CompletedFirst Submitted
Initial submission to the registry
October 26, 2020
CompletedFirst Posted
Study publicly available on registry
November 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedOctober 2, 2024
October 1, 2024
3.1 years
October 26, 2020
October 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Protein - tissue
3 years
Transcriptomics (RNA) - blood
3 years
Cytokines - blood
3 years
Other Outcomes (1)
Antibodies - blood
3 years
Interventions
This is a non-interventional study
Eligibility Criteria
Patients with sarcoidosis
You may qualify if:
- 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.
You may not qualify if:
- \. Evidence of acute bacterial infection or other condition likely in the opinion of the investigator to significantly impact results of blood assays.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hull University Teaching Hospitals NHS Trustlead
- University of Yorkcollaborator
Study Sites (1)
Castle Hill Hospital
Cottingham, East Yorkshire, HU16 5JQ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2020
First Posted
November 19, 2020
Study Start
November 11, 2019
Primary Completion
December 31, 2022
Study Completion
December 31, 2023
Last Updated
October 2, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share