Actively Recruiting
Prospective Evaluation of Diagnosis and Treatment of Patients With Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic/Autoimmune Neutropenia
Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2024-10-15
200
Participants Needed
1
Research Sites
834 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this observational study is to characterize the diagnostic and therapeutic management of autoimmune cytopenias including autoimmune hemolytic anemia, immune thrombocytopenia, and chronic idiopathic/autoimmune neutropenia. The main aims to answer are: * evaluation of traditional and novel diagnostic tools including immunohematology, cytokine essays, bone marrow studies, molecular findings, and fecal microbiome. * evaluation of type and sequence of the therapies administered, the response rates, and the adverse events. * evaluation of clinical and laboratory (immunologic, molecular, and morphologic) predictors of outcome. * evolution of autoimmune cytopenias into myelodysplastic syndromes. * a subgroup of patients with myelodysplastic syndromes will be included to evaluate the presence of immunologic events, autoimmune activation, and red cell metabolism. Participants will receive a clinical/laboratory diagnostic workup as per current clinical practice. Furthermore They will be sampled at baseline (peripheral blood and feces for microbiome) and followed up for at least 3 years to evaluate their clinical course, therapeutic management and outcome.
CONDITIONS
Official Title
Prospective Evaluation of Diagnosis and Treatment of Patients With Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic/Autoimmune Neutropenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of autoimmune cytopenias (AIHA, ITP, CIN, AIN)
- Age 18 years or older
- Ability to sign informed consent
- Willingness to undergo at least 3 years of follow-up
- For patients with myelodysplastic syndrome: bone marrow showing 10% or more dysplastic features in at least one lineage with MDS-related cytopenia or cytogenetics
You will not qualify if you...
- Any condition preventing informed consent
- Diagnosis of immune cytopenia made 6 months or more before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy, 20100
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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