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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU Amiens-Picardie
RECRUITING
Amiens
CHRU Lille
NOT_YET_RECRUITING
Lille
CHU Rouen
NOT_YET_RECRUITING
Rouen
Contact Information
Primary
Loïc Garçon, PD
garcon.loic@chu-amiens.fr
33 3 22 08 70 56
Backup
Annabelle Boussault
boussault.annabelle@chu-amiens.fr
Time Frame
Start Date: 2018-06-15
Estimated Completion Date: 2024-12
Participants
Target number of participants: 300
Sponsors
Leads: Centre Hospitalier Universitaire, Amiens

This content was sourced from clinicaltrials.gov