NCT05931718 Prospective Evaluation of Diagnosis and Treatment of Patients With Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic/Autoimmune Neutropenia
| NCT ID | NCT05931718 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
| Condition | Autoimmune Hemolytic Anemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2019-06-01 |
| Primary Completion | 2030-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2019-06-01 with a primary completion date of 2030-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Frequently Asked Questions
Who can join the NCT05931718 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Autoimmune Hemolytic Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05931718 currently recruiting?
Yes, NCT05931718 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico to inquire about joining.
Where is the NCT05931718 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT05931718 clinical trial?
NCT05931718 is sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. The trial plans to enroll 200 participants.