Recombinant erythropoietin in autoimmune hemolytic anemia with inadequate bone marrow response: a prospective analysis.
Bruno Fattizzo, Giacinto Luca Pedone, Caterina Brambilla...
https://pubmed.ncbi.nlm.nih.gov/38029356Actively Recruiting
Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2024-10-15
200
Participants Needed
1
Research Sites
247 weeks
Total Duration
Researchers are studying autoimmune cytopenias, including autoimmune hemolytic anemia, immune thrombocytopenia, and chronic idiopathic/autoimmune neutropenia, to better understand how these conditions are diagnosed and treated. The study also includes a subgroup of patients with myelodysplastic syndromes to investigate immune activation and red blood cell metabolism. The goal is to evaluate diagnostic tools, treatment types, responses, and predictors of outcomes over time. Participants will be observed without receiving experimental treatments. They will undergo clinical and laboratory evaluations such as immunohematology, cytokine assays, bone marrow studies, molecular tests, and fecal microbiome analysis. Patients will be sampled at diagnosis and followed for at least three years to track their clinical course, therapies used, response rates, relapses, and any complications like infections or thromboses. Throughout the study, participants will provide samples including peripheral blood and feces for detailed laboratory analyses. Researchers will assess the sensitivity and specificity of diagnostic tests and monitor various biological markers, including cytokine levels and somatic mutations. Data on treatment safety and effectiveness in routine practice will be collected, and participants will be regularly monitored for up to three years to understand the progression and outcomes of their conditions.
CONDITIONS
Prospective Evaluation of Diagnosis and Treatment of Patients With Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic/Autoimmune Neutropenia
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At diagnosis
Participants undergo diagnostic evaluations including blood sampling for cytokine and genetic analyses, fecal sample collection for microbiome studies, and bone marrow evaluation if clinically indicated.
1 to 2 visits depending on clinical indication
Duration - Up to 5 years
Participants are followed over time to collect data on treatments, responses, relapses, complications, and outcomes according to their specific autoimmune cytopenia or myelodysplastic syndrome subtype.
Periodic follow-up visits during the monitoring period
Total: 1 location
1
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy, 20100
Actively Recruiting
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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Bruno Fattizzo, Giacinto Luca Pedone, Caterina Brambilla...
https://pubmed.ncbi.nlm.nih.gov/38029356Francesco Versino, Nicoletta Revelli, Stefania Villa...
https://pubmed.ncbi.nlm.nih.gov/38013593