Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2018-03-09
2024-12-31
Brief Summary
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Time points: at inclusion, after 6 months, after 12 months, then yearly up to 4 years after inclusion.
No intervention, mere observation and documentation. Guided pre-inclusion (differential) diagnostic work-up.
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Detailed Description
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Primary Goal:
Rapid detection of underlying causes of severe immune cytopenias with the aid of a structured diagnostic approach and access to a clinical care network of the participating centers, allowing early treatment stratification
Secondary Goals:
* Collection of data about epidemiology of rare diseases
* Systemic documentation of response rates to various treatments
* Identification of biomarkers and modifiers of immune tolerance
* Collection of data about the usage of novel/experimental therapeutic agents
* Documentation of physician-reported outcome measures/performance scores
* Consultation of the caring physicians through a regular SIC-Reg board
There will be no additional venous punctures or investigational time points. At clinical visits around planned study time points, additional blood parameters and stool specimen will be obtained. The current clinical management follows international guidelines, which are summarized in the study documents but do not represent part of the study (no diagnostic or therapeutic investigational arm).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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patients
all who fulfil inclusion criteria and consent to participation; potential biomarkers will be documented
potential biomarkers
facs analysis, microbiome analysis
Interventions
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potential biomarkers
facs analysis, microbiome analysis
Eligibility Criteria
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Inclusion Criteria
* Evans syndrome (ES)
* Persistent or chronic immune thrombocytopenia (ITP; \>6 months after first manifestation)
Exclusion Criteria
* (history of) hematopoietic stem cell transplantation
6 Months
25 Years
ALL
No
Sponsors
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Medical University of Graz
OTHER
Responsible Party
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Principal Investigators
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Seidel
Role: PRINCIPAL_INVESTIGATOR
Medical University of Graz
Locations
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Pediatric Hematology-Oncology Outpatient Clinic
Graz, Styria, Austria
Countries
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Other Identifiers
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30-155 ex 17/18
Identifier Type: -
Identifier Source: org_study_id
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