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

NCT ID: NCT07157189

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-09-30

Study Completion Date

2027-12-30

Brief Summary

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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

Detailed Description

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This research is designed to comprehensively characterize Behçet's disease (BD), an inflammatory multisystem disorder with variable prevalence and presentation based on geography and ethnicity. Data will be collected from patients attending the Rheumatology, Rehabilitation and Physical Medicine department, Assiut University Hospitals, capturing demographic profiles, disease manifestations, laboratory results, and therapeutic history. The study uses validated criteria (ISG and rICBD) for BD diagnosis, focusing on thorough examination across musculoskeletal, dermatological, ocular, vascular, gastrointestinal, and neurological domains. Disease activity and severity will be assessed using standardized forms (Behcet's disease current activity form 2006, BODI). Laboratory analysis includes CBC, acute phase reactants, and organ function tests. Data management incorporates advanced statistical techniques using SPSS, aiming for rigorous analysis to inform future BD management in the region .

Conditions

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Behçet's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* Patients with unconfirmed diagnosis of BD.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Sara Maher

resident at the Rheumatology, Rehabilitation and Physical Medicine department

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 39101633 (View on PubMed)

Other Identifiers

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Analysis of Behçet's Disease

Identifier Type: -

Identifier Source: org_study_id

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