Flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression in myelodysplastic neoplasms (MPO-MDS-Valid): protocol for a multicentre diagnostic accuracy study.

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  • Additional Information
    • Source:
      Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
    • Publication Information:
      Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
    • Subject Terms:
      Flow Cytometry* ; Peroxidase*/blood ; Peroxidase*/metabolism ; Neutrophils*/metabolism ; Myelodysplastic Syndromes*/diagnosis ; Myelodysplastic Syndromes*/blood; Humans ; Cross-Sectional Studies ; Reproducibility of Results ; France ; Male ; Multicenter Studies as Topic ; Female ; Sensitivity and Specificity ; Adult
    • Abstract:
      Introduction: Many patients referred for suspicion of myelodysplastic neoplasm (MDS) are subjected to unnecessary discomfort from bone marrow aspiration, due to the low disease prevalence in this population. Flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression could rule out MDS with sensitivity and negative predictive value estimates close to 100%, ultimately obviating the need for bone marrow aspiration in up to 35% of patients. However, the generalisability of these findings is uncertain due to the limited sample size, the enrolment of patients at a single study site, and the reliability issues associated with laboratory-developed tests and varying levels of operator experience. This study aims to validate the accuracy attributes of peripheral blood neutrophil myeloperoxidase expression quantified by flow cytometric analysis in an independent multicentre sample.
      Methods and Analysis: The MPO-MDS-Valid project is a cross-sectional diagnostic accuracy study comparing an index test to a reference standard. Consecutive adult patients referred for suspicion of MDS are being recruited at seven university hospitals and one cancer centre in France. At each site, flow cytometric analysis of peripheral blood samples is performed by operators who are blinded to the reference diagnosis. A central adjudication committee whose members are unaware of the index test results will determine the reference diagnosis of MDS, based on cytomorphological evaluation of bone marrow performed in duplicate by experienced hematopathologists. The target sample size is 400 patients and the anticipated study recruitment completion date is 31 December 2025.
      Ethics and Dissemination: An institutional review board (Comité de Protection des Personnes Nord-Ouest III, Caen, France) approved the protocol, prior to the start of the study. Participants are recruited using an opt-out approach. Efforts will be made to publish the primary results within 6 months after study completion.
      Trial Registration Number: NCT05175469.
      Competing Interests: Competing interests: None declared.
      (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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    • Contributed Indexing:
      Keywords: Aged; HAEMATOLOGY; STATISTICS & RESEARCH METHODS
    • Molecular Sequence:
      ClinicalTrials.gov NCT05175469
    • Accession Number:
      EC 1.11.1.7 (Peroxidase)
    • Publication Date:
      Date Created: 20240618 Date Completed: 20240618 Latest Revision: 20240923
    • Publication Date:
      20240924
    • Accession Number:
      PMC11191800
    • Accession Number:
      10.1136/bmjopen-2023-081200
    • Accession Number:
      38889946