Prospective Multiethnic Validation of the Behçet's Syndrome Overall Damage Index (BODI) (NCT07073261) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Prospective Multiethnic Validation of the Behçet's Syndrome Overall Damage Index (BODI)
Italy970 participantsStarted 2021-07-23
Plain-language summary
PROBE is an observational multicenter cohort study, consisting of a cross-sectional and a 5-years prospective phase, designed to target the major study objectives, such as testing the comprehensiveness of the Behçet's syndrome Overall Damage Index (BODI) in a wide and ethnically heterogeneous cohort of Behçet's syndrome patients, and investigating how damage assessed by the BODI correlates with other major long-term disease outcomes (5-years mortality and hospitalization rates).
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of BS according to ICBD or ISG criteria.
Exclusion Criteria:
* Subjects unable or unwilling to make themselves available for the duration of the study and/or are unwilling to follow interval visits.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying a damage index called BODI in Behçet's Syndrome patients across different ethnic groups — could you explain what BODI measures and whether tracking it over five years might give us useful information about how my condition is progressing?
2Since the trial is no longer actively recruiting, is there any chance I could still be considered for participation, or are there similar observational studies for Behçet's Syndrome that I might be eligible to join?
3The trial is measuring five-year mortality and hospitalization rates — what does that tell us about the severity of Behçet's Syndrome in the populations being studied, and how does that relate to my own situation and prognosis?
4Because this is an observational validation study rather than a treatment trial, it wouldn't change my therapy directly — so should my focus right now be on finding an interventional trial or optimizing my current treatment plan instead?
5Since this study is designed to be multiethnic, does the ethnic background of a patient affect how Behçet's Syndrome tends to present or progress, and is that something we should factor into decisions about my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.