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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03621241
Acronym
MODIFY
Enrollment
300
Registered
2018-08-08
Start date
2018-06-15
Completion date
2024-12-31
Last updated
2024-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndromes

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

Interventions

DIAGNOSTIC_TESTFlow cytometry

Flow cytometry

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
identification of the most relevant combination of FC markers0 daysThe main objective is to identify the most relevant combination of FC markers to discriminate between already diagnosed MDS patients and non-MDS patients.

Secondary

MeasureTime frameDescription
prospective validation of a diagnostic score using pre-identified markers0 daysThe secondary objective is to build prospectively a diagnostic score using markers identified

Countries

France

Contacts

Primary ContactLoïc Garçon, PD
garcon.loic@chu-amiens.fr33 3 22 08 70 56
Backup ContactAnnabelle Boussault
boussault.annabelle@chu-amiens.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026