Recruiting NCT06377462
Multicenter, Interdisciplinary National VEXAS Registry With Accompanying Biomaterial Collection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: VEXAS Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The aim is rapid collection of real-life data on the epidemiology, treatment and disease course in patients with VEXAS syndrome during routine clinical practice and collect biomaterials to evaluate genotype-phenotype associations, determine optimal treatment schedule, identify diagnostic features and biomarkers
Detailed description
see brief summary
Primary outcome measures
- Collection of epidemiological data on VEXAS [Time frame: enrollment]
- Collection and monitoring of initial disease manifestations [Time frame: 5 years]
- Documentation of the treatment approaches and therapy sequences [Time frame: 5 years]
- Analysis of clinical-relevant clinical endpoints [Time frame: 5 years]
Secondary outcome measures (6)
- Describe disease cluster [Time frame: 5 years]
- Laboratory diagnostics [Time frame: 5 years]
- Correlation clinical endpoints with treatment approaches [Time frame: 5 years]
- Quality of life data (QoL), fatigue questionnaire (Facit-F) [Time frame: 5 years]
- Accompanying translational research [Time frame: 5 years]
- Collection of Biospecimens [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Patients with established or suspected (clinical and hematological criteria) VEXAS Syndrome
- Age ≥18 years
- Signed informed consent form
Exclusion criteria
- patients who are not in a position to understand the nature and scope of participation in this register
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 17 centers
- Universitätsklinikum Aachen — Aachen
- Klinikum Chemnitz gGmbH — Chemnitz
- Universitätsklinikum Carl Gustav Carus — Dresden
- Universitätsklinikum Düsseldorf — Düsseldorf
- Evang. Kliniken Essen-Mitte — Essen
- Universitätsmedizin Göttingen — Göttingen
- Universitätsklinikum Hamburg-Eppendorf — Hamburg
- Universitätsklinikum Jena — Jena
- … and 9 more centers
Identifiers
NCT: NCT06377462 · VEXAS-Registry