Follows adults with autoimmune blood cell disorders and their treatment course
Studies how autoimmune anemia, low platelets and neutropenia are diagnosed and treated.
Key facts
- Who runs it
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Where
- Milan, ItalySee the site
- Trial code
- Registry title
- Prospective Evaluation of Diagnosis and Treatment of Patients With Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic/Autoimmune Neutropenia
- Status
- Recruiting
- People taking part
- 200 people, planned
- Started
- 1 Jun 2019
- Expected to end
- Jun 2035
- Type of study
- Observational, 4 groups
- Treatments tested
- cytokine essays
- NGS
- Fecal microbiome
- Erythropoietin
- Luspatercept
- Thrombopoietin Receptor Agonist
- G-CSF
- Record updated
- 15 October 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with an autoimmune cytopenia (AIHA, ITP, CIN or AIN), who will be followed for 3 years. A group with myelodysplastic syndrome can also join.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Diagnosis of an autoimmune cytopenia: AIHA, ITP, CIN or AIN. For the myelodysplastic syndrome group: bone marrow with at least 10% dysplastic features in at least one cell line, plus MDS-defining low blood counts and/or MDS-defining cytogenetics.
Main reasons for not taking part
- Any condition that stops the person from giving informed consent
- Immune cytopenia diagnosed 6 months or more before enrolment
- Not available for 3 years of follow-up
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- any condition impeding the acquisition of the informed consent
- immune cytopenia diagnosis preceding >/= 6 months the enrolment
Where in Italy
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyContact: Bruno Fattizzo, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 4 groups in the trial
- Autoimmune hemolytic anemia
AIHA patients will be enrolled at diagnosis and stratified according to AIHA type (i.e. warm, cold, mixed, and atypical forms), sampled for peripheral blood for cytokine and NGS studies, and for feces for microbiome studies. If clinically indicated, bone marrow evaluation will be performed and a sample for single cell analysis will be collected. Patients will be followed up to collect treatments, responses, relapses, and complications (particularly thromboses and infections).
Treatment: cytokine essays, NGS, Fecal microbiome, and Erythropoietin
- Immune thrombocytopenia
ITP patients will be enrolled at diagnosis and sampled for peripheral blood for cytokine and NGS studies, and for feces for microbiome studies. If clinically indicated, bone marrow evaluation will be performed and a sample for single cell analysis will be collected.Patients will be followed up to collect treatments, responses, relapses, and complications (particularly thromboses and infections).
Treatment: cytokine essays, NGS, Fecal microbiome, and Thrombopoietin Receptor Agonist
- Chronic idiopathic neutropenia/Autoimmune neutropenia
CIN/AIN patients will be enrolled at diagnosis and sampled for peripheral blood for cytokine and NGS studies, and for feces for microbiome studies. If clinically indicated, bone marrow evaluation will be performed and a sample for single cell analysis will be collected.Patients will be followed up to collect treatments, responses, relapses, and complications (particularly infections).
Treatment: cytokine essays, NGS, Fecal microbiome, and G-CSF
- Myelodysplastic syndromes
MDS patients will be enrolled at diagnosis and sampled for peripheral blood for cytokine and NGS studies, and to evaluate red cell metabolism. If clinically indicated, bone marrow evaluation will be performed and a sample for single cell analysis will be collected. Patients will be followed up to collect treatments, responses, relapses, and outcome.
Treatment: cytokine essays, NGS, Fecal microbiome, and Luspatercept
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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.
- Plain-language title
- Follows adults with autoimmune blood cell disorders and their treatment courseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 15 October 2024