RecruitingNCT07081087

Replacing Bone Marrow Diagnostics With Peripheral Blood Analysis in Cytopenia Patients

Development of a Peripheral Blood Assay to Replace BM Evaluation in Cytopenia - a Multi-Center Observational Study

Sponsor

Weizmann Institute of Science

Enrollment

1,500 participants

Start Date

Jun 1, 2025

Study Type

OBSERVATIONAL

Conditions

MDS Cytopenia

Summary

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

Min Age: 18 Years

Inclusion Criteria5

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
For both sexes, no evidence of Iron, folinic acid, or B12 deficiency

Exclusion Criteria5

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.
Patients who have undergone a bone marrow transplant.

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Interventions

DIAGNOSTIC_TESTPERIBLOOD-MDS

In 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