Evaluation of diagnosis and treatment for autoimmune cytopenias
Evaluation of the Diagnostic/Therapeutic Course of Patients With Autoimmune Cytopenias (Autoimmune Hemolytic Anemia AIHA, Immune Thrombocytopenia ITP, Chronic Idiopathic/Autoimmune Neutropenia CIN/AIN) and Identification of Predictive and Prognostic Markers.
This study is trying to understand how autoimmune cytopenias are diagnosed and treated, looking at different tests and treatments to see what works best for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT05931718 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize the diagnostic and therapeutic management of autoimmune cytopenias, including autoimmune hemolytic anemia, immune thrombocytopenia, and chronic idiopathic/autoimmune neutropenia. It will evaluate traditional and novel diagnostic tools, the types and sequences of therapies administered, response rates, and adverse events. Additionally, it will assess clinical and laboratory predictors of outcomes and the evolution of autoimmune cytopenias into myelodysplastic syndromes. A subgroup of patients with myelodysplastic syndromes will also be included to investigate immunologic events and red cell metabolism.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with autoimmune cytopenias.
Not a fit: Patients with conditions that prevent them from providing informed consent or those diagnosed with immune cytopenia for more than six months prior to enrollment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and treatment strategies for patients with autoimmune cytopenias.
How similar studies have performed: While there have been studies on autoimmune cytopenias, this specific approach focusing on a comprehensive evaluation of diagnostic and therapeutic management is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of autoimmune cytopenias (AIHA/ITP/CIN/AIN) * age \>/= 18 years * ability to sign informed consent * availability to undergo 3 year follow up * for the subgroup of patients with myelodysplastic syndrome: bone marrow evaluation showing \>/= 10% dysplastic features of at least one lineage along with MDS defining cytopenia and/or MDS defining cytogenetics. Exclusion Criteria: * any condition impeding the acquisition of the informed consent * immune cytopenia diagnosis preceding \>/= 6 months the enrolment
Where this trial is running
Milan
- Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico — Milan, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.