Immune Thrombocytopenia Clinical Trial
— sic-regOfficial title:
Register für Schwere Immunzytopenien - Severe Immune Cytopenia Registry (SIC-Reg.Org)
Verified date | January 2024 |
Source | Medical University of Graz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Prospective registry study for children and young adults with severe immune cytopenias (persisting/chronic immune thrombocytopenia, autoimmune hemolytic anemia, and Evans syndrome) to improve the management, facilitate the differential diagnostic work-up, and document the clinical course under various treatments. 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.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 25 Years |
Eligibility | Inclusion Criteria: - Autoimmune hemolytic anemia (AIHA) - Evans syndrome (ES) - Persistent or chronic immune thrombocytopenia (ITP; >6 months after first manifestation) Exclusion Criteria: - (history of) malignancies - (history of) hematopoietic stem cell transplantation |
Country | Name | City | State |
---|---|---|---|
Austria | Pediatric Hematology-Oncology Outpatient Clinic | Graz | Styria |
Lead Sponsor | Collaborator |
---|---|
Medical University of Graz |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | underlying disease that causes or is associated with severe immune cytopenia | identify the underlying condition or other disease, e.g., primary immunodeficiency or bone marrow failure syndrome by diagnostic procedures according to a standardized algorithm | 0-4 years | |
Secondary | Clinical course | Documentation of physician-reported clinical symptoms including outcome measures/performance scores | 0-4 years | |
Secondary | Biomarkers - Blood | Identification of novel biomarkers by flow cytometry of leukocytes | 0-4 years | |
Secondary | Biomarkers - Stool | Identification of potential modifiers of immune tolerance by studying the intestinal microbiome | 0-4 years | |
Secondary | Routine laboratory parameters | documentation of laboratory parameters that are routinely assessed for immune cytopenia | 0-4 years | |
Secondary | Number of participants with the diagnosis of severe immune cytopenia per participating centre and per year | epidemiological data acquisition, participants included according to the inclusion criteria | 0-4 years |
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