Actively Recruiting

Age: 18Years +
All Genders
ID05931718

Evaluation of Diagnosis and Treatment of Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic/Autoimmune Neutropenia with Predictive Marker Identification

Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2024-10-15

200

Participants Needed

1

Research Sites

247 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief 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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of autoimmune cytopenias (autoimmune hemolytic anemia, immune thrombocytopenia, chronic idiopathic/autoimmune neutropenia)
  • Age 18 years or older
  • Ability to provide informed consent
  • Willingness to undergo follow-up for at least 3 years
  • For myelodysplastic syndrome subgroup: bone marrow showing 10% or more dysplastic features of at least one cell lineage with MDS-defining cytopenia or cytogenetics
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Long-term Monitoring

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

Trial Site Locations

Total: 1 location

1

Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy, 20100

Actively Recruiting

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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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Published Research Related To This Trial

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/38029356