Severe Immune Cytopenia Registry Www.Sic-reg.Org

  • STATUS
    Recruiting
  • End date
    Mar 8, 2026
  • participants needed
    50
  • sponsor
    Medical University of Graz
Updated on 2 April 2021
anemia
cytopenia
thrombocytopenia
evans syndrome
autoimmune hemolytic anemia
autoimmune thrombocytopenia

Summary

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.

Description

The study aims to improve the management and care of patients with severe immune cytopenias, to identify underlying causes of severe immune cytopenias and to develop a strategy for early treatment stratification based on a standardized diagnostic algorithm, potentially supported by biomarker analyses and (off study) genetic analyses, where clinically indicated.

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).

Details
Condition IDIOPATHIC THROMBOCYTOPENIC PURPURA, Autoimmune disease, Autoimmune hemolytic anemia, Primary Immunodeficiency, Immune Thrombocytopenia, Primary Immunodeficiency Disorders, Idiopathic Thrombocytopenic Purpura (ITP), Thrombocytopenic, Evan Syndrome, Primary Cold Agglutinin Disease, Evans Syndrome, Primary Immune Deficiencies, autoimmune thrombocytopenia
Treatment potential biomarkers
Clinical Study IdentifierNCT03576742
SponsorMedical University of Graz
Last Modified on2 April 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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