Inducible Co-stimulator Gene With Systemic Lupus Erythematosus
ICOS/SLE
Association of ICOS Gene Polymorphism With Susceptibility and Severity of Systemic Lupus Erythematosus.
1 other identifier
observational
30
1 country
1
Brief 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.
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 Jun 2026
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
June 1, 2026
CompletedFirst Submitted
Initial submission to the registry
June 23, 2026
CompletedFirst Posted
Study publicly available on registry
June 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
June 30, 2026
May 1, 2026
1 year
June 23, 2026
June 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
ICOS gene polymorphism and SLE
association between ICOS gene polymorphism and SLE susceptibility
6 month
Secondary Outcomes (1)
systemic lupus erythematosus (SLE) Assessment
6 month
Study Arms (2)
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.
Eligibility Criteria
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
You may qualify if:
- Patients diagnosed with SLE based on 2019 EULAR/ACR Male or female. willing to provide written informed consent for participation and genetic testing
You may not qualify if:
- Other autoimmune diseases or chronic inflammatory disorders. Malignancy. Pregnancy or breastfeeding. Inability to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Valley University Hospital
Qina, Egypt
Biospecimen
Blood samples are collected from SLE patients and healthy controls. Genotyping: Real-time polymerase chain reaction (PCR) genotyping for ICOS will be done with the TaqMan-Allelic discrimination method in a Step One Plus Real-Time PCR system (Applied Biosystems, Foster City, CA, USA), and the results will be analyzed using the Allelic Discrimination software program (Applied Biosystems). We will purchase the specific probe designed for SNP rs11889031 (T\>C) (product No. C\_430016\_10) and TaqMan genotyping master mix from Applied Biosystems.
Study Officials
- STUDY CHAIR
Eisa Mohammed Hegazy, Professor
Dermatology, Venereology & Andrology Department ,Faculty of Medicine ,South Valley University.
- STUDY DIRECTOR
Mohammed Hosny Hassan, Professor
Biochemistry , Qena faculty of medicine ,south valley university.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident
Study Record Dates
First Submitted
June 23, 2026
First Posted
June 30, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
June 30, 2026
Record last verified: 2026-05