NCT07845162

Brief Summary

This cross-sectional study aims to evaluate serum Epstein-Barr virus-induced gene 3 (EBI-3) protein levels in patients with Behçet's disease compared with healthy controls.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
16mo left

Started Sep 2026

Status
not yet recruiting

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 Progress2%
Sep 2026Jan 2028

First Submitted

Initial submission to the registry

September 22, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

September 26, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2028

Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 22, 2026

Last Update Submit

September 22, 2026

Conditions

Keywords

Behçet's diseaseEBI-3 SerumbiomarkerAssiut

Outcome Measures

Primary Outcomes (1)

  • Mean serum EBI-3 protein level

    Mean serum Epstein-Barr virus-induced gene 3 (EBI-3) protein concentration measured by ELISA in patients with Behçet's disease compared with healthy controls.

    Baseline

Secondary Outcomes (4)

  • Serum EBI-3 level according to disease activity

    Baseline

  • Serum EBI-3 level in patients with vascular involvement

    Baseline

  • Serum EBI-3 level in patients with ocular involvement

    Baseline

  • Serum EBI-3 level in patients with neurological involvement

    Baseline

Study Arms (2)

Behçet's Disease

Patients diagnosed with Behçet's disease according to the International Criteria for Behçet's Disease.

Healthy Controls

Age-matched healthy individuals without autoimmune or inflammatory diseases.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with Behçet's disease attending the Physical Medicine, Rheumatology and Rehabilitation Department at Assiut University Hospitals, and healthy controls.

You may qualify if:

  • \- Age 18 years or older
  • Diagnosis of Behçet's disease according to the International Criteria for Behçet's Disease (cases)
  • Healthy individuals without autoimmune or inflammatory diseases (controls)
  • Written informed consent

You may not qualify if:

  • \- Other autoimmune disorders (RA, SLE, psoriatic arthritis, ankylosing spondylitis)
  • Acute or chronic infection
  • Malignancy or history of malignancy
  • Chronic liver disease or advanced chronic kidney disease
  • Pregnancy or lactation
  • Vasculitis caused by diseases other than Behçet's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Behcet Syndrome

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesUveitis, AnteriorPanuveitisUveitisUveal DiseasesEye DiseasesVasculitisVascular DiseasesCardiovascular DiseasesHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Vascular

Study Officials

  • Gehan I Abdelraziq, prof

    Physical Medicine, Rheumatology and Rehabilitation Department, Assiut University Hospitals

    STUDY CHAIR

Central Study Contacts

Shrouk S Mohamed, Resident

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician, Department of Physical Medicine, Rheumatology and Rehabilitation

Study Record Dates

First Submitted

September 22, 2026

First Posted

September 28, 2026

Study Start

September 26, 2026

Primary Completion (Estimated)

September 26, 2027

Study Completion (Estimated)

January 25, 2028

Last Updated

September 28, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share