Here is the design of a clinical trial:

Official Title: Development and Prospective Validation of a Standardized Flow Cytometric Assay of Peripheral Blood Neutrophil Myeloperoxidase Expression for Ruling Out Myelodysplastic Syndromes.

Included conditions:
- Myelodysplastic Syndromes

Study Armgroups:

Interventions:
- {'type': 'OTHER', 'name': 'Diagnostic Test: Flow cytometry analysis of neutrophil myeloperoxidase expression', 'description': 'Flow cytometry analysis of neutrophil myeloperoxidase expression in peripheral blood samples will be performed within 24 h of MDS diagnostic evaluation and blinded to the reference standard. Peripheral blood samples will be collected in 5 ml (EDTA) anticoagulant plastic tubes and processed within 24 h maximum of collection.\n\nBlood sample will be stained according to the manufacturers\' recommendations with a lyophilized cocktail ("LyotubeTM ready-to-use", BD Bioscience).\n\nAt least 10,000 neutrophils will be acquired on a 3-laser, 8-color BD FACSCanto-II TM flow cytometer (BD Biosciences, San José, CA).\n\nEach marker will be expressed as median, geometric and arithmetic mean, regular and robust coefficient of variation.'}

Primary Outcomes:
- {'measure': 'Reference diagnosis of MDS or CMML established by bone marrow examination', 'description': 'The primary outcome is the reference diagnosis of MDS or CMML established by bone marrow examination (with Perls staining) by two independent experienced hematopathologists blinded to the index test results. Disagreements will be solved by a third hematopathologist. Bone marrow aspirate will be repeated within 4 to 6 months for patients with idiopathic cytopenia of uncertain significance (ICUS) or non-conclusive bone marrow examination.', 'timeFrame': 'Baseline'}

Please estimate the sample size based on the assumption: 
22% prevalence of MDS, 20% rate of uninterpretable or inconclusive bone marrow aspirates
Sample size
        Assuming an area under the ROC curve point estimate of 0.90, we estimated that an effective sample size of 82 participants with a 22% prevalence of MDS would provide a precision of Â±0.10 (95% CI ranging from 0.80 to 1.00). Anticipating a 20% rate of uninterpretable or inconclusive bone marrow aspirates, 21 additional patients will be recruited, leading to an overall sample size of 103 patients. The sample size was estimated with PASS V.15 (NCSS, LLC. Kaysville, Utah, USA).