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Active, not recruiting Observational

Prospective Multiethnic Validation of the Behçet's Syndrome Overall Damage Index (BODI)

NCT07073261 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2021-07-23
Last updated
2025-07-18

Condition(s) studied

Behçet's Syndrome (BS)

Study 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).

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 5-years mortality rate — 5 years
    Correlation between the irreversible organ damage measured by the BEhçet's syndrome Overall Damage Index (BODI) and the 5-years mortality rate.
  • 5-years hospitalization rate — 5 years
    Correlation between the irreversible organ damage measured by the BEhçet's syndrome Overall Damage Index (BODI) and the 5-years hospitalization rate.

Trial sites (1)

FacilityCityRegionStatus
Rheumatology Unit, University and AOU of Cagliari Monserrato Cagliari
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07073261 on ClinicalTrials.gov ↗ ← All trials in Italy