Systemic Lupus ErthematosusICOS/SLENCT07675837
Inducible Co-stimulator Gene With Systemic Lupus Erythematosus
An observational study of Systemic Lupus Erthematosus, run by South Valley University at 1 site in Egypt.
Trial summary
The aim of this study is to investigate the association between ICOS gene polymorphism and susceptibility to systemic lupus erythematosus (SLE), as well as its impact on disease severity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erthematosus
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2026to Jul 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: group A: systemic lupus erythrematosus patients about 20 patients diagnosed with SLE based on 2019 EULAR/ACR. group B:healthy controls 10 with no personal or family history of autoimmune diseases or chronic inflammatory disorders
Who may be able to join
- Patients diagnosed with SLE based on 2019 EULAR/ACR Male or female. willing to provide written informed consent for participation and genetic testing
Who cannot join
- Other autoimmune diseases or chronic inflammatory disorders. Malignancy. Pregnancy or breastfeeding. Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
South Valley University Hospital
Qina
Ebtehal Alaa El-din Kotp, lecturer, +201066798383, Ebtehal-alaa@med.svu.edu.eg
Shimaa Saber Ahmed, lecturer, +201006393764, shimaasaber063@gmail.com
About this study
Official title: Association of ICOS Gene Polymorphism With Susceptibility and Severity of Systemic Lupus Erythematosus.
The aim of this study is to investigate the association between ICOS gene polymorphism and susceptibility to systemic lupus erythematosus (SLE), as well as its impact on disease severity.
Read the detailed description
Systemic lupus erythematosus (SLE) is a chronic, multiorgan, systemic autoimmune disease that affects almost all tissue and organ systems, has a varied clinical appearance, and fluctuates in severity among people and over time. The global incidence of SLE has been estimated at 5.14 per 100,000 person-years with mortality rates ranging from 6.7 to 37.8 %, with women five times more likely to be affected than men. The pathogenesis of SLE is complex and involves cells of both innate and adaptive immunity. The distinguishing feature of SLE is the production of autoantibodies, with the formation of immune complexes , and result in the inflammatory response of the immune system.Costimulatory signals, which include ligands and receptors and their interactions involving multiple types of signal information, are essential for the initiation, maintenance, and regulation of immune reactions. When costimulatory factors malfunction, complex abnormal immune responses with biological effects and ultimately clinical autoimmune diseases result. Inducible co-stimulator (ICOS) is the third member of the CD28/cytotoxic T-lymphocyte associated antigen-4 family and is involved in the proliferation and activation of T cells. The inducible T cell co-stimulator (ICOS) is expressed on T cells following peptide:MHC engagement with CD28 co-stimulation. The interaction of ICOS with its sole ligand the Inducible T-cell co-stimulatory ligand (ICOSL; also known as B7-related protein-1 or ICOSL) triggers key activities of T cells including cytokine production and differentiation into the T follicular helper (Tfh) cell lineage over effector lineages. Inducible T-cell co-stimulator (ICOS)-deficient people are unable to produce T follicular helper (Tfh) cells, which are CD4 T cells that migrate into B cell follicles and promote germinal centre (GC) reactions, according to research on human patients and mice models.
In this study, we aim to explore the possible association between potentially functional SNP rs11889031 of the ICOS gene and SLE in the Egyptian population.
- Conditions
- Systemic Lupus Erthematosus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group A: systemic lupus erythrematosus | about 20 patients diagnosed with SLE based on 2019 EULAR/ACR. | |
| group B:healthy controls | 10 with no personal or family history of autoimmune diseases or chronic inflammatory disorders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICOS gene polymorphism and SLE
association between ICOS gene polymorphism and SLE susceptibility
Measured: 6 month
Secondary outcomes (1)
systemic lupus erythematosus (SLE) Assessment
the impact of the ICOS gene polymorphism on disease severity and activity using the Systemic Lupus Erythematosus Disease Activity Index Index (SLEDAI).
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErthematosusStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Fetouh Abdel Latif, South Valley University
- Investigators
- Eisa Mohammed Hegazy, Professor, Study chair, Dermatology, Venereology & Andrology Department ,Faculty of Medicine ,South Valley University.Mohammed Hosny Hassan, Professor, Study director, Biochemistry , Qena faculty of medicine ,south valley university.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675837
- Sponsor's protocol ID
- DVA021
- Acronym
- ICOS/SLE
- Status last verified
- May 2026
- First submitted
- 23 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of ICOS Gene Polymorphism With Susceptibility and Severity of Systemic Lupus Erythematosus.
- ClinicalTrials.gov ID
- NCT07675837
- Acronym / sponsor ID
- ICOS/SLE / DVA021
- Conditions
- Systemic Lupus Erthematosus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 30 Jun 2026 (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.
The aim of this study is to investigate the association between ICOS gene polymorphism and susceptibility to systemic lupus erythematosus (SLE), as well as its impact on disease severity.
Detailed description
Systemic lupus erythematosus (SLE) is a chronic, multiorgan, systemic autoimmune disease that affects almost all tissue and organ systems, has a varied clinical appearance, and fluctuates in severity among people and over time. The global incidence of SLE has been estimated at 5.14 per 100,000 person-years with mortality rates ranging from 6.7 to 37.8 %, with women five times more likely to be affected than men. The pathogenesis of SLE is complex and involves cells of both innate and adaptive immunity. The distinguishing feature of SLE is the production of autoantibodies, with the formation of immune complexes , and result in the inflammatory response of the immune system.Costimulatory signals, which include ligands and receptors and their interactions involving multiple types of signal information, are essential for the initiation, maintenance, and regulation of immune reactions. When costimulatory factors malfunction, complex abnormal immune responses with biological effects and ultimately clinical autoimmune diseases result. Inducible co-stimulator (ICOS) is the third member of the CD28/cytotoxic T-lymphocyte associated antigen-4 family and is involved in the proliferation and activation of T cells. The inducible T cell co-stimulator (ICOS) is expressed on T cells following peptide:MHC engagement with CD28 co-stimulation. The interaction of ICOS with its sole ligand the Inducible T-cell co-stimulatory ligand (ICOSL; also known as B7-related protein-1 or ICOSL) triggers key activities of T cells including cytokine production and differentiation into the T follicular helper (Tfh) cell lineage over effector lineages. Inducible T-cell co-stimulator (ICOS)-deficient people are unable to produce T follicular helper (Tfh) cells, which are CD4 T cells that migrate into B cell follicles and promote germinal centre (GC) reactions, according to research on human patients and mice models.
In this study, we aim to explore the possible association between potentially functional SNP rs11889031 of the ICOS gene and SLE in the Egyptian population.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A: systemic lupus erythrematosus | – | –about 20 patients diagnosed with SLE based on 2019 EULAR/ACR. |
| group B:healthy controls | – | –10 with no personal or family history of autoimmune diseases or chronic inflammatory disorders. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- group A: systemic lupus erythrematosus patients about 20 patients diagnosed with SLE based on 2019 EULAR/ACR. group B:healthy controls 10 with no personal or family history of autoimmune diseases or chronic inflammatory disorders
Key inclusion criteria (1 listed)
- Patients diagnosed with SLE based on 2019 EULAR/ACR Male or female. willing to provide written informed consent for participation and genetic testing
Key exclusion criteria (1 listed)
- Other autoimmune diseases or chronic inflammatory disorders. Malignancy. Pregnancy or breastfeeding. Inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ICOS gene polymorphism and SLE
Time frame: 6 month
association between ICOS gene polymorphism and SLE susceptibility
1 secondary outcome
systemic lupus erythematosus (SLE) Assessment
Time frame: 6 month
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 30 Jun 2026.
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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.
Eisa Mohammed Hegazy, Professor study chair
Dermatology, Venereology & Andrology Department ,Faculty of Medicine ,South Valley University.
Mohammed Hosny Hassan, Professor study director
Biochemistry , Qena faculty of medicine ,south valley university.
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 Systemic Lupus Erthematosus, run by South Valley University at 1 site in Egypt.
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 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: opening soon, as of the sponsor's last update on 30 Jun 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 Egypt. 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 Dina Fetouh Abdel-latif, MSc (+201283364643, dedemoona@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICOS gene polymorphism and SLE (time frame: 6 month). 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 30 Jun 2026.