Clinical, Laboratory, and Therapeutic Analysis of Behçet's Disease in Assiut

NCT07157189 | Not Yet Recruiting

• 1 other identifier: Analysis of Behçet's Disease
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

A cross-sectional, observational study surveying the clinical, laboratory, and therapeutic characteristics of Behçet's disease patients in a tertiary care center in Upper Egypt

Conditions

Behçet's Disease

Keywords

Behçet's disease; therapeutic profile

Outcome Measures

Primary Outcomes (1)

• Proportion of key clinical manifestations in Behçet's disease patients

  This outcome will systematically quantify how often major clinical features-such as recurrent oral ulcers, genital ulcers, ocular lesions (including chronic relapsing uveitis), and musculoskeletal involvement, appear within the studied Behçet's disease population, in accordance with predefined diagnostic criteria

  Baseline

Study Arms (1)

Behçet's disease patients

adults and adolescents diagnosed using international criteria (ISG and rICBD), with recurrent oral ulceration and at least two additional manifestations (genital ulcers, eye lesions, skin lesions, positive pathergy test).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Eligible participants are adults and adolescents diagnosed using international criteria (ISG and rICBD), with recurrent oral ulceration and at least two additional manifestations (genital ulcers, eye lesions, skin lesions, positive pathergy test). Patients with unconfirmed BD are excluded. Given BD's variable age and gender distribution, the population will reflect regional epidemiological trends, including a probable male predominance consistent with Arab and Mediterranean cohorts. Comprehensive sociodemographic data, disease duration, age at onset, family/personal history, and clinical presentation are documented. All patients are monitored through a structured two-year inclusion, maximizing sample heterogeneity and capturing real-world data from both inpatient and outpatient clinical pathways .

You may qualify if:

• Patients who fulfil the international study group criteria (ISG) which require the presence of recurrent oral ulceration plus at least two of the following: recurrent genital ulcers, eye lesions (uveitis or retinal vasculitis), skin lesions, or a positive pathergy test (12). and the revised International Criteria of BD (rICBD)

You may not qualify if:

• Patients with unconfirmed diagnosis of BD.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Fazaa A, Makhlouf Y, Ben Massoud F, Miladi S, Boussaa H, Ouenniche K, Souebni L, Kassab S, Chekili S, Ben Abdelghani K, Laatar A. Behcet disease: epidemiology, classification criteria and treatment modalities. Expert Rev Clin Immunol. 2024 Dec;20(12):1437-1448. doi: 10.1080/1744666X.2024.2388693. Epub 2024 Aug 11.

  PMID: 39101633 BACKGROUND

MeSH Terms

Conditions

Behcet Syndrome

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident at the Rheumatology, Rehabilitation and Physical Medicine department

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share