Immunophenotyping of Blood Cells in the Diagnosis Work-up of Myelodysplastic Syndromes

Myelodysplastic Syndromes Clinical Trial

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Official title:

Immunophenotyping of Blood Cells in the Diagnosis Work-up of Myelodysplastic Syndromes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03621241
• Other study ID #: PI2018_843_0010
• Status: Recruiting
• Start date: June 15, 2018
• Est. completion date: May 17, 2024

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Loïc Garçon, PD
• Phone: 33 3 22 08 70 56
• Email: garcon.loic[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 17, 2024
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient who have been orally informed, and given a short written information notice about the study

2. Adult patient>18 years

3. For whom a blood sample analysis is routinely prescribed

4. 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).

5. 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:

1. Transfused patients (less than 3 months) in RBC or platelets units

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Diagnostic Test:
• Flow cytometry
Flow cytometry

Locations

Country	Name	City	State
France	CHU Amiens-Picardie	Amiens
France	CHRU Lille	Lille
France	CHU Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	identification of the most relevant combination of FC markers	The main objective is to identify the most relevant combination of FC markers to discriminate between already diagnosed MDS patients and non-MDS patients.	0 days
Secondary	prospective validation of a diagnostic score using pre-identified markers	The secondary objective is to build prospectively a diagnostic score using markers identified	0 days