Analyzing blood samples to diagnose myelodysplastic syndromes without bone marrow aspiration
Flow Cytometric Analysis of Peripheral Blood Neutrophil Myeloperoxidase Expression for Ruling Out Myelodysplastic Syndromes: Protocol for a Diagnostic Accuracy Study
This study is testing a new blood test to see if it can accurately diagnose myelodysplastic syndromes without the need for a painful bone marrow procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 8 sites (Clermont-Ferrand and 7 other locations) |
| Trial ID | NCT05175469 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the accuracy of flow cytometric analysis of neutrophil myeloperoxidase expression in peripheral blood as a non-invasive diagnostic tool for myelodysplastic syndromes (MDS). It involves a multicenter approach where consecutive patients referred for suspicion of MDS will undergo this blood test, which will be compared against traditional bone marrow examination results. The primary goal is to determine how effectively this blood test can rule out MDS, potentially reducing unnecessary invasive procedures. Secondary objectives include assessing the negative predictive value of the test and identifying alternative diagnoses in patients ruled out for MDS.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are referred for suspicion of myelodysplastic syndrome and have indications for bone marrow examination.
Not a fit: Patients with a history of or active myelodysplastic syndromes or chronic myelomonocytic leukemia will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for invasive bone marrow aspirations in patients suspected of having MDS.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel method for diagnosing MDS.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age at enrollment ≥18 years * Referral for suspicion of myelodysplastic syndrome * Indication for bone marrow examination * ≥1 peripheral blood cytopenia defined by hemoglobin concentration \<12 g/dL for female and \<13g/dL for male patients, platelet count \<150 x109/L, absolute neutrophil count \<1.8 x109/L * Inpatient or outpatient care Exclusion Criteria: * Refusal to participate * History of or active documented MDS or CMML * Enrollment in intensive or critical care unit * Incarcerated or individuals protected by French regulation (Article L1121.5 and following, Code de la Santé Publique) * Not affiliated with social security system * Previous enrollment in the study
Where this trial is running
Clermont-Ferrand and 7 other locations
- University Hospital, Clermont-Ferrand — Clermont-Ferrand, France (Not_yet_recruiting)
- Grenoble_Alpes UniversityHospital — Grenoble, France (Recruiting)
- University Hospital Lyon Sud, HCL — Lyon, France (Recruiting)
- Institut Paoli Calmettes — Marseille, France (Recruiting)
- University Hospital Saint-Eloi — Montpellier, France (Recruiting)
- Chu Nantes — Nantes, France (Recruiting)
- University Hospital NICE — Nice, France (Recruiting)
- University Hospital, Saint-Étienne — Saint-Étienne, France (Recruiting)
Study contacts
- Principal investigator: Tatiana RASKOVALOVA — University Hospital, Grenoble
- Study coordinator: Tatiana RASKOVALOVA
- Email: traskovalova@chu-grenoble.fr
- Phone: 04 76 76 63 34
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.