SarcoidosisNCT04637165
Exploring the Immunology of Sarcoidosis
An observational study of Sarcoidosis, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- This is a non-interventional study
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Nov 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with sarcoidosis
Who may be able to join
- 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.
Who cannot join
- 1. Evidence of acute bacterial infection or other condition likely in the opinion of the investigator to significantly impact results of blood assays.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Castle Hill Hospital
Cottingham, East Yorkshire, HU16 5JQ
About this study
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.
- Conditions
- Sarcoidosis
- Being tested
- This is a non-interventional study
- Keywords
- macrophage, lymphocyte, cytokine, immunology
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a non-interventional studyOther
This is a non-interventional study
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (3)
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.
Measured: 3 years
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.
Measured: 3 years
Cytokines - blood
Inflammatory mediator concentrations in unstimulated and stimulated blood samples.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start11 Nov 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of York
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637165
- Sponsor's protocol ID
- R2421
- Status last verified
- Oct 2024
- First submitted
- 26 Oct 2020
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Immunology of Sarcoidosis
- ClinicalTrials.gov ID
- NCT04637165
- Acronym / sponsor ID
- R2421
- Conditions
- Sarcoidosis
- Keywords
- macrophage, lymphocyte, cytokine, immunology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Collaborators
- University of York
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sarcoidosis
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Evidence of acute bacterial infection or other condition likely in the opinion of the investigator to significantly impact results of blood assays.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is a non-interventional studyThis is a non-interventional study | Other | – |
Primary outcome
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 secondary outcomes
Protein - tissue
Time frame: 3 years
Transcriptomics (RNA) - blood
Time frame: 3 years
Cytokines - blood
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Sarcoidosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Repurposing Tilmanocept for Cardiac Sarcoidosis
Cardiac Sarcoidosis
RecruitingObservational study
Cardiac Sarcoidosis Multi-Center Prospective Cohort
Cardiac Sarcoidosis
RecruitingPhase 2/3
A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis
Cutaneous Sarcoidosis
Not yet recruitingPhase 2
An Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
Pulmonary Sarcoidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcriptomics (RNA) -tissue (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.