Analyzing blood cells to improve diagnosis of myelodysplastic syndromes
Immunophenotyping of Blood Cells in the Diagnosis Work-up of Myelodysplastic Syndromes
This study is testing if certain markers on blood cells can help doctors diagnose myelodysplastic syndromes more accurately and without needing painful bone marrow biopsies for older patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 3 sites (Amiens and 2 other locations) |
| Trial ID | NCT03621241 on ClinicalTrials.gov |
What this trial studies
This study focuses on myelodysplastic syndromes (MDS), a group of blood disorders characterized by ineffective blood cell production. It aims to evaluate specific flow cytometry markers on blood cells to develop a diagnostic score that can differentiate between MDS and non-clonal hematopoiesis. By analyzing a large cohort of patients, the study seeks to reduce the need for invasive bone marrow biopsies in elderly patients who present with cytopenias. The findings could lead to a more accurate and less invasive diagnostic approach for MDS.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who present with cytopenia and are suspected of having myelodysplastic syndromes.
Not a fit: Patients who have received blood transfusions within the last three months will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive diagnostic method for myelodysplastic syndromes, improving patient comfort and outcomes.
How similar studies have performed: Preliminary studies have shown promise in using flow cytometry markers for diagnosing MDS, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Amiens and 2 other locations
- CHU Amiens-Picardie — Amiens, France (Recruiting)
- CHRU Lille — Lille, France (Not_yet_recruiting)
- CHU Rouen — Rouen, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Loïc Garçon, PD
- Email: garcon.loic@chu-amiens.fr
- Phone: 33 3 22 08 70 56
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.