At each study site, data are collected prospectively by the investigator or a designated representative, using an electronic standardised case report form (box 1). A final data review will be performed to check for validity, consistency, omissions or any apparent discrepancies before the database is locked. Access to the study data is restricted to clinical research assistants, investigators and data managers.
Recorded data
Gender.
Age at enrolment.
History of haematological disease.
Alternate diagnosis as likely as MDS.
History of or ongoing antineoplastic chemotherapy, radiotherapy, immunosuppressive or biological therapy.
History of occupational exposure.
Complete blood count with reticulocyte count.
Peripheral blood biochemical test results (C reactive protein, creatinine, BUN, liver profile (AST, ALT, gamma-glutamyl transferase, alkaline phosphatase, bilirubin), TSH, ferritin, haptoglobin, serum vitamin B12 and serum folate).
Flow cytometry MO1 if CMML suspected (supporting criteria).
Date and time of peripheral blood collection.
Storage conditions and date and time of index test processing.
Robust coefficient of variation for neutrophil myeloperoxidase expression in peripheral blood.
Date and time of bone marrow aspiration.
Cytomorphological assessment of bone marrow aspirate.
MDS/CMML status by reference method.
MDS/CMML subtype categorisation according to WHO classification.31
Percentage of bone marrow blasts.
Bone marrow megakaryocytic dysplasia.
Bone marrow erythroid dysplasia.
Bone marrow myeloid dysplasia.
Bone marrow ring sideroblasts.
Bone marrow karyotype
Bone marrow fluorescence in situ hybridisation.
Bone marrow flow cytometry score.33
International Prognostic Scoring System.34
Revised International Prognostic Scoring System.35
Next-generation sequencing panel
Alternate diagnosis in unconfirmed cases of MDS.
Repeat bone marrow aspirate findings for patients with ICUS, CCUS or uninterpretable/inconclusive bone marrow aspirate at baseline.
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ALT, alanine aminotransferase; AST, aspartate aminotransferase; BUN, blood urea nitrogen; CCUS, clonal cytopenia of undetermined significance; CMML, chronic myelomonocytic leukemia; ICUS, idiopathic cytopenia of undetermined significance; MDS, myelodysplastic syndrome; TSH, thyroid-stimulating hormone.
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