Clinical Phenotype and Prevalence of VEXAS Syndrome in Internal Medicine (NCT07708688) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Phenotype and Prevalence of VEXAS Syndrome in Internal Medicine
50 participantsStarted 2026-07
Plain-language summary
The FIND-VEXAS project is a multicenter, cross-sectional observational study conducted in Internal Medicine departments in the Friuli Venezia Giulia region of Italy.
The study aims to estimate how frequently VEXAS syndrome occurs among adults older than 50 years who are admitted to Internal Medicine units with otherwise unexplained systemic inflammation or hematologic abnormalities, such as fever, elevated inflammatory markers, macrocytic anemia, thrombocytopenia, or other cytopenias.
Participants will be assessed using clinical information, physical examination findings, routine laboratory tests, and imaging data. Patients with findings suggestive of VEXAS syndrome will be selected for confirmatory genetic testing of the UBA1 gene using blood or bone marrow samples.
In addition to estimating the prevalence of genetically confirmed VEXAS syndrome, the study will describe the clinical manifestations, hematologic abnormalities, inflammatory profile, and organ involvement of patients with suspected or confirmed disease.
Who can participate
Age range
50 Years
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:
* Age older than 50 years.
* Admission to a participating Internal Medicine department within the FADOI Friuli Venezia Giulia network.
* Presence of otherwise unexplained systemic inflammation and/or hematologic abnormalities.
* At least one of the following clinical or laboratory findings:
* unexplained fever;
* elevated C-reactive protein and/or erythrocyte sedimentation rate;
* macrocytic anemia;
* thrombocytopenia or other cytopenias;
* systemic inflammatory manifestations without a clearly identified cause.
* Availability of clinical, laboratory, and imaging data required for assessment according to the study screening pathway.
* Provision of informed consent, where required by the approved study protocol and applicable regulations.
Exclusion Criteria:
* Systemic inflammation adequately explained by an active infection.
* Systemic inflammation adequately explained by a solid malignancy.
* Clinical or laboratory abnormalities with another clearly established etiology.
* Insufficient clinical or laboratory information to assess eligibility according to the study screening pathway.
* Inability or refusal to provide informed consent, where consent is required.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Prevalence of Genetically Confirmed VEXAS Syndrome
Timeframe: Through study completion, up to 24 months