HealthyNCT04698291
Genetic Variants and Regulation of Specialized Pro-resolving Mediator
An observational study of Healthy and Inflammatory Disease, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
Inflammation is the way that the body reacts against infection, injury or illness. An uncontrolled inflammatory response can lead to the development of inflammatory diseases, such as rheumatoid arthritis and cardiovascular conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Inflammatory Disease, Cardiovascular Diseases
- What is being tested?
- Blood Donation
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 May 2021to 8 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Genes \& Health is a huge long-term study of 100,000 people of Bangladeshi and Pakistani origin focuses to link genes with health records and to study disease and treatments. We will be focused on those volunteers with specific mutations in Specialized pro-resolving mediators enzymes and receptors.
Who may be able to join
- Current volunteer of the Genes \& Health program with (test) or without (control) relevant genetic mutations. Genes \& Health is a huge long-term study of 100,000 people of Bangladeshi and Pakistani origin focuses to link genes with health records and to study disease and treatments. When a volunteer participates in this program, they agree to the possibility to be invited for further studies. Gene \& Health program invites volunteers to take part in two regions of the UK: East London and Bradford.
Who cannot join
- Volunteer that has not had their genome sequenced after taking part in Stage 1 of Genes \& Health program.
- Volunteer with significant genetically inherited conditions.
- 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.
- Volunteer that went under surgery and are recovering.
- 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.
- Presence or history of drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Mary University of London
London, EC1M 6BQ
Esteban A Gomez Cifuentes, PhD student, +447741093970, e.a.g.c.cifuentes@qmul.ac.uk
Esteban A Gomez Cifuentes, PhD Student
About this study
Official title: Identifying the Effect of Genetic Variants on Specialized Pro-resolving Mediators and Their Association With Chronic Inflammatory Conditions
Inflammation is the way that the body reacts against infection, injury or illness. An uncontrolled inflammatory response can lead to the development of inflammatory diseases, such as rheumatoid arthritis and cardiovascular conditions. Recent studies have shown that inflammation is a regulated process coordinated by a group of molecules known as specialized pro-resolving mediator (SPM). These molecules are produced by enzymes via the enzymatic conversion of essential fatty acids; whereas their biological actions are mediated by proteins expressed on the surface of cells known as receptors.
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.
Read the detailed description
This study aims to identify polymorphisms in SPM-related genes in a South Asian population and assess whether these lead to alterations in the functions of enzymes and proteins encoded by these genes. This information will then be used to identify those SNP (Single nucleotide polymorphism) that lead to loss of function. We will then evaluate whether these SNP are linked with altered white blood cell function and increased incidence of chronic inflammatory disorders by assessing data from the Gene \& Health program and other databases such as UK Biobank. We expect that this approach will provide new insights into molecular mechanisms and the identification of new mediators/enzyme/receptors families that are dysregulated in inflammatory conditions.
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
- Healthy, Inflammatory Disease, Cardiovascular Diseases
- Being tested
- Blood Donation
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DonationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Blood Donation | |
| 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. Receives: Procedure: Blood Donation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid Mediator Profiling
The blood samples will be used to get the lipid mediator profiling (specialized pro-resolving mediators abundance in blood) using a liquid chromatography in tandem mass spectrometry strategy).
Measured: Inmediately after blood sample collection.
Secondary outcomes (4)
Phagocytosis
Phagocytosis will be assayed in vitro by measuring the engulfment of Escherichia coli by T cells and Macrophage. The extent of phagocytosis will be assessed using flow cytometry.
Measured: Up to 6 month after blood sample collection.
Platelet activation
Adhesion molecule expression as well as platelet-leukocyte aggregates will be assessed using flow cytometry.
Measured: Up to 6 month after blood sample collection.
Peripheral blood T-cell assay
T-cell activity will be assessed using cytokine expression as well as the expression of activation markers by flow cytometry.
Measured: Up to 6 month after blood sample collection.
Peripheral blood SPM pathways
Enzyme and receptor expression associated with specialized pro resolving mediators will be assessed using flow cytometry.
Measured: Up to 6 month after blood sample collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start6 May 2021
- Primary completion5 Oct 2027 (estimated)
- Study completion8 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesmond Dalli, Professor, Study director, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698291
- Sponsor's protocol ID
- 291815
- Status last verified
- Feb 2026
- First submitted
- 18 Dec 2020
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Any results arising from this study will be kept to support future research projects. The information will only be released to recognised researchers whose project has been approved by ethics and medical research committees in the UK. The researchers may be given access to some information about the volunteers health, but will not be given any personal information that can be used to identify them.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying the Effect of Genetic Variants on Specialized Pro-resolving Mediators and Their Association With Chronic Inflammatory Conditions
- ClinicalTrials.gov ID
- NCT04698291
- Acronym / sponsor ID
- 291815
- Conditions
- Healthy, Inflammatory Disease, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- 5 Oct 2027 (estimated)
- Study completion
- 8 Dec 2027 (estimated)
- First posted
- 6 Jan 2021 (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.
Inflammation is the way that the body reacts against infection, injury or illness. An uncontrolled inflammatory response can lead to the development of inflammatory diseases, such as rheumatoid arthritis and cardiovascular conditions. Recent studies have shown that inflammation is a regulated process coordinated by a group of molecules known as specialized pro-resolving mediator (SPM). These molecules are produced by enzymes via the enzymatic conversion of essential fatty acids; whereas their biological actions are mediated by proteins expressed on the surface of cells known as receptors.
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
This study aims to identify polymorphisms in SPM-related genes in a South Asian population and assess whether these lead to alterations in the functions of enzymes and proteins encoded by these genes. This information will then be used to identify those SNP (Single nucleotide polymorphism) that lead to loss of function. We will then evaluate whether these SNP are linked with altered white blood cell function and increased incidence of chronic inflammatory disorders by assessing data from the Gene \& Health program and other databases such as UK Biobank. We expect that this approach will provide new insights into molecular mechanisms and the identification of new mediators/enzyme/receptors families that are dysregulated in inflammatory conditions.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls | – | Procedure: Blood DonationThis 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. |
| Cases | – | Procedure: Blood DonationThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Genes \& Health is a huge long-term study of 100,000 people of Bangladeshi and Pakistani origin focuses to link genes with health records and to study disease and treatments. We will be focused on those volunteers with specific mutations in Specialized pro-resolving mediators enzymes and receptors.
Key inclusion criteria (1 listed)
- Current volunteer of the Genes \& Health program with (test) or without (control) relevant genetic mutations. Genes \& Health is a huge long-term study of 100,000 people of Bangladeshi and Pakistani origin focuses to link genes with health records and to study disease and treatments. When a volunteer participates in this program, they agree to the possibility to be invited for further studies. Gene \& Health program invites volunteers to take part in two regions of the UK: East London and Bradford.
Key exclusion criteria (6 listed)
- Volunteer that has not had their genome sequenced after taking part in Stage 1 of Genes \& Health program.
- Volunteer with significant genetically inherited conditions.
- 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.
- Volunteer that went under surgery and are recovering.
- 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.
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 |
|---|---|---|
| Blood DonationThe 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. | Procedure or surgery | Cases, Controls |
Primary outcome
Lipid Mediator Profiling
Time frame: Inmediately after blood sample collection.
The blood samples will be used to get the lipid mediator profiling (specialized pro-resolving mediators abundance in blood) using a liquid chromatography in tandem mass spectrometry strategy).
4 secondary outcomes
Phagocytosis
Time frame: Up to 6 month after blood sample collection.
Platelet activation
Time frame: Up to 6 month after blood sample collection.
Peripheral blood T-cell assay
Time frame: Up to 6 month after blood sample collection.
Peripheral blood SPM pathways
Time frame: Up to 6 month after blood sample collection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Gene \& Health program informationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Any results arising from this study will be kept to support future research projects. The information will only be released to recognised researchers whose project has been approved by ethics and medical research committees in the UK. The researchers may be given access to some information about the volunteers health, but will not be given any personal information that can be used to identify them.
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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.
Jesmond Dalli, Professor study director
Queen Mary University of London
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 Healthy and Inflammatory Disease, run by Queen Mary University of London 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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 5 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esteban A Gomez Cifuentes, PhD student (+447741093970, e.a.g.c.cifuentes@qmul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid Mediator Profiling (time frame: Inmediately after blood sample collection.). 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 5 Feb 2026.