Status:
ACTIVE_NOT_RECRUITING
Development and Prospective Validation of a Standardized Flow Cytometric Assay of Peripheral Blood Neutrophil Myeloperoxidase Expression for Ruling Out Myelodysplastic Syndromes.
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18-100 years
Brief Summary
Myelodysplastic syndromes (MDS) comprise a heterogeneous group of clonal bone marrow neoplasms that predominate in the elderly, with a median age at diagnosis of 70 years. The diagnosis of MDS relies ...
Detailed Description
The primary objective of MPO-MDS-develop study is to estimate the discriminative accuracy (i.e., area under the ROC curve along with 95% CI) of a standardized and semi-automatic flow cytometric assay ...
Eligibility Criteria
Inclusion
- Age at enrollment ≥18 years
- Clinical suspicion of MDS
- 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 and outpatient care patients
Exclusion
- Refusal to participate
- History of or active documented MDS
- 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.
Key Trial Info
Start Date :
July 27 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT04399018
Start Date
July 27 2020
End Date
December 1 2024
Last Update
March 19 2024
Active Locations (1)
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1
Chu Grenoble Alpes
Grenoble, France, 38043