NCT07675837

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

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
11mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Jun 2026Jul 2027

Study Start

First participant enrolled

June 1, 2026

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 30, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

June 30, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

June 23, 2026

Last Update Submit

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

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

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

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

  • Eisa Mohammed Hegazy, Professor

    Dermatology, Venereology & Andrology Department ,Faculty of Medicine ,South Valley University.

    STUDY CHAIR
  • Mohammed Hosny Hassan, Professor

    Biochemistry , Qena faculty of medicine ,south valley university.

    STUDY DIRECTOR

Central Study Contacts

Dina Fetouh Abdel-latif, MSc

CONTACT

Soheir abdel- Hamid Ali, lecturer

CONTACT

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

Locations