Genetic Variants and Regulation of Specialized Pro-resolving Mediator
NCT ID: NCT04698291
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2021-05-06
2025-12-08
Brief Summary
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Given the central role that pro-resolving mediators play in regulating the immune response, the aim of this study is to investigate whether there are genetic variants (mutations) in genes encoding for enzymes and receptors involved in the biology of these molecules and to determine how these mutations affect SPM's activity or function.
Findings made as part of these studies will help shed light into mechanism influencing disease onset and/or progression and potentially enhance the discovery of new and more effective treatments.
Detailed Description
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To achieve this aim, we will identify volunteers from the Gene \& Health program. The Gene \& Health program has sequenced around 40,000 volunteers and identified around 500 gene variants that are predicted to lead to complete loss of gene function; among these SNP, 68 are presented in enzymes and receptors related with SPM including ALOX15, GPR18 and FPR2/ALX. As part of their recruitment to Gene \& Health program, participants have consented to be contacted about future research studies such as this.
In order to study the differences in the lipid mediator profiles between the groups, we will use peripheral blood obtained from consented Gene \& Health individuals that present the SNP of interest (cases) and individuals without the mutation (controls). For the lipid mediator profiling a liquid chromatography in tandem mass spectrometry strategy (LC-MS/MS) will be used. Cell biology assays (phagocytosis, platelet activation, etc.) will be conducted using peripheral blood phagocytes cells. In addition, volunteers will be consented for access to their centralised health records so we can identify associations between different polymorphisms and the development of inflammatory conditions through a candidate-gene association study.
The risks of this study to participants are low and relate to the sharing of confidential data and blood sample donation. Access to confidential clinical information with person-identifiable data will be restricted to the Chief Investigator and Principal Investigator, who are aware of their responsibilities under the Data Protection Act 2018 and all the obligations related to data management enforced by Gene \& Health program. As for the blood donation, we believe that there is minimal risk to participants as they will only be asked to donate up to 60 ml of blood per sitting and donors will not be recalled more than 3 separate occasions.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Controls
This research aims to recruit only adult volunteers that have taken part of the Gene \& Health program. We will focus on two groups: individuals presenting the polymorphisms of interest and individuals without the genetic variants in the genes of interest, which will be used as matched controls. Eligible individuals will consent to donate blood samples for this study, in addition to consent access to their medical and health records.
Blood Donation
The blood donation will take place at the Gene \& Health clinical assessment centre facilities. A trained member from Gene \& Health program will be responsible for taking the blood samples.
Cases
This research aims to recruit only adult volunteers that have taken part of the Gene \& Health program. We will focus on two groups: individuals presenting the polymorphisms of interest and individuals without the genetic variants in the genes of interest, which will be used as matched controls. Eligible individuals will consent to donate blood samples for this study, in addition to consent access to their medical and health records.
Blood Donation
The blood donation will take place at the Gene \& Health clinical assessment centre facilities. A trained member from Gene \& Health program will be responsible for taking the blood samples.
Interventions
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Blood Donation
The blood donation will take place at the Gene \& Health clinical assessment centre facilities. A trained member from Gene \& Health program will be responsible for taking the blood samples.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Volunteer with significant genetically inherited conditions.
3. Any abnormality or pre-existing disease which, in the opinion of the investigator, might either expose the subject to risk, or influence the validity of the results.
4. Volunteer that went under surgery and are recovering.
5. Participation in a clinical study of a new chemical entity, biological product or a prescription medicine, or loss of more than 400 mL blood, within the previous 3 months.
6. Presence or history of drug or alcohol abuse.
18 Years
ALL
Yes
Sponsors
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Queen Mary University of London
OTHER
Responsible Party
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Principal Investigators
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Jesmond Dalli, Professor
Role: STUDY_DIRECTOR
Queen Mary University of London
Locations
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Queen Mary University of London
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Gene \& Health program information
Other Identifiers
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291815
Identifier Type: -
Identifier Source: org_study_id