ClinicalTrials.gov record NCT07157189
Clinical, Laboratory, and Therapeutic Analysis of Behçet's Disease in Assiut
Clinical, Laboratory and Therapeutic Profile of Behçet's Disease Patients in Tertiary Center in Upper Egypt
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This observational study will record clinical signs, lab results, and treatment histories from people with Behçet's disease diagnosed by international criteria. It uses standardized activity and severity forms and routine blood tests to describe how the disease appears and is treated. The study is designed to capture a varied patient population over a defined enrollment period.
What it is studying. The study aims to describe the clinical features, laboratory findings, disease activity, and therapeutic profiles of people diagnosed with Behçet's disease.
What the researchers hope to learn. Scientifically, the study seeks to quantify how often key clinical features occur, document laboratory and organ-function findings, and map current treatment patterns to inform future understanding of Behçet's disease in the studied population.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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 .
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will provide medical and treatment history and undergo a clinical examination across affected systems (musculoskeletal, skin, eyes, vascular, gastrointestinal, neurological). They will complete standardized disease-activity and severity forms (Behçet's Disease Current Activity Form 2006, BODI) and have routine blood tests (for example CBC, inflammatory markers, and organ function tests). Data from visits and tests will be recorded for analysis; participants are described as being followed within a structured two-year inclusion period.
How the study is structured. An observational, prospective cohort study: researchers will collect data from clinic patients without assigning any treatments. Data include a medical exam across affected systems, standardized disease-activity forms, and routine laboratory tests; records of past and current therapies will also be kept.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Behçet's Disease. Does it apply to my diagnosis?
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- No sites are listed on the registry yet. Where will the study take place?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on familial Mediterranean fever
This trial is also listed on this site under Behçet's disease.
Important dates
- Study start
- Sep 30, 2026 (estimated)
- Primary completion
- Nov 30, 2027 (estimated)
- Study completion
- Dec 30, 2027 (estimated)
- Target enrollment
- 30 participants (estimated)
- Last updated on registry
- Sep 5, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Assiut University
- Principal investigator
- Sara Maher, resident at the Rheumatology, Rehabilitation and Physical Medicine department
Assiut University
Participating sites
Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins.
Terms used on this page · explanations by MedicalUpdates.ai
- study group
- One of the groups in a study. Each arm receives a particular intervention, comparator or no intervention, so the groups can be compared.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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