Immunophenotyping of Blood Cells in the Diagnosis Work-up of Myelodysplastic Syndromes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 300
- Locations
- 3
- Primary Endpoint
- identification of the most relevant combination of FC markers
Study Overview
Brief Summary
Myelodysplastic syndromes (MDS) are a heterogeneous group of hematological malignancies characterized by cytopenia(s), dysplasia in one or more major myeloid cell lines and progression to acute leukemia. Morphological analysis of peripheral blood (PB) and bone marrow (BM) remains the cornerstone of the diagnosis. Preliminary studies identified Flow Cytometry (FC) markers on red cells, platelets and circulating leukocytes that are expressed differently in MDS and in controls. However, these markers have been evaluated separately. The investigators propose to test in a large cohort of patients these markers, and to combine the most relevant ones in order to define a PB FC-based diagnosis score that would discriminate between MDS and non-clonal hematopoiesis and would avoid useless bone marrow samples in elderly
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient who have been orally informed, and given a short written information notice about the study
- •Adult patient>18 years
- •For whom a blood sample analysis is routinely prescribed
- •Presenting cytopenia on at least one lineage according to the 2016 WHO classification (Hemoglobin level<100 g/L and/or platelets <150 G/L and/or Neutrophils<1G/L).
- •For whom a bone marrow analysis for morphology assessment and cytogenetics have to be performed, because of suspicion of MDS.t The results of this bone marrow evaluation will classify the patients in Group 1 (MDS diagnosis) and Group 2 (no MDS according to the 2016 WHO criteria), defining the two populations of this validation cohort for whom the FC score will be calculated.
Exclusion Criteria
- •Transfused patients (less than 3 months) in RBC or platelets units
Outcomes
Primary Outcomes
identification of the most relevant combination of FC markers
Time Frame: 0 days
The main objective is to identify the most relevant combination of FC markers to discriminate between already diagnosed MDS patients and non-MDS patients.
Secondary Outcomes
- prospective validation of a diagnostic score using pre-identified markers(0 days)