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

NCT03621241 | Recruiting

• 1 other identifier: PI2018_843_0010
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

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

Conditions

Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• prospective validation of a diagnostic score using pre-identified markers

  0 days

Interventions

Flow cytometry DIAGNOSTIC_TEST

Flow cytometry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MDS

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (3)

CHU Amiens-Picardie

Amiens, 80054, France

RECRUITING

CHRU Lille

Lille, 59000, France

NOT YET RECRUITING

CHU Rouen

Rouen, 76031, France

NOT YET RECRUITING

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Flow Cytometry

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Loïc Garçon, PD

CONTACT

33 3 22 08 70 56; garcon.loic@chu-amiens.fr

Annabelle Boussault

CONTACT

boussault.annabelle@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: August 8, 2018
• Study Start: June 15, 2018
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)