About this trial
This observational, multi-center study aims to collect data in order to develop a novel, minimally invasive diagnostic tool for MDS based on peripheral blood profiling of circulating hematopoietic stem and progenitor cells (cHSPCs) using single-cell RNA sequencing and DNA sequencing.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 and up with suspected/confirmed MDS cases referred to BM evaluation either for diagnosis or risk assessment due to cytopenia
Platelets < 150 × 10E9/L or
Absolute neutrophil count < 1.8 × 10E9/L or
Hemoglobin (Hgb) < 13 g/dL (males) and < 12 g/dL (female) and
Disqualifiers
Women who are pregnant
Previous diagnosis of leukemia; AML, MPN, ALL, CLL, MGUS/MM or any other gammopathy
Lymphocytes > 5000/ul
Patients who are on disease-related therapy are excluded, unless they are treated with Erythropoietin or Prednisone. See Appendix 2 for the list of excluded treatments.
Trial population
Patients with cytopenia, who are referred to BM from the primary care clinic will be recruited to the study
Trial design
Cohort
Prospective
Treatments tested in this trial
PERIBLOOD-MDS
Diagnostic testIn the study, peripheral blood will be taken from all patients, shipped and analyzed at the Weizmann Institute of Science to produce a report based on our technology. The report will contain data on the diagnosis, blast counts and karyotype. This information will be compared with the results from the bone marrow scan, taken separately to each patient, to validate the accuracy of our technology
Treatment groups
Trial outcomes
Primary outcomes
To develop PERIBLOOD-MDS diagnostic test of PB cHPCs for the diagnosis of MDS
Comparison between PERIBLOOD-MDS diagnosis and bone marrow evaluation of MDS
Sponsors and contacts
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