A blood test to replace bone marrow exams for diagnosing cytopenias and MDS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-center observational effort that collects peripheral blood from adults referred for bone marrow evaluation because of unexplained cytopenias. Researchers will perform single-cell RNA sequencing and DNA sequencing of circulating hematopoietic stem and progenitor cells (cHSPCs) and compare the resulting blood-based calls to conventional bone marrow diagnoses. The team will use a previously developed reference map and computational pipeline to classify samples and will examine whether the blood profiles can also stratify MDS risk. Secondary analyses will estimate how often a validated blood test could reduce the need for invasive bone marrow procedures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients aged 18 and up with suspected/confirmed MDS cases referred to BM evaluation either for diagnosis or risk assessment due to cytopenia
2. Platelets \< 150 × 10E9/L or
3. Absolute neutrophil count \< 1.8 × 10E9/L or
4. Hemoglobin (Hgb) \< 13 g/dL (males) and \< 12 g/dL (female) and
5. For both sexes, no evidence of Iron, folinic acid, or B12 deficiency

Exclusion Criteria:

1. Women who are pregnant
2. Previous diagnosis of leukemia; AML, MPN, ALL, CLL, MGUS/MM or any other gammopathy
3. Lymphocytes \> 5000/ul
4. 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.
5. Patients who have undergone a bone marrow transplant.

Where it's running

• University of California San Diego
  San Diego, California, United States Recruiting
• University of Miami
  Miami, Florida, United States Recruiting

Study contacts

• Principal investigator: Liran Shlush — The Weizmann Institute of Science
• Study coordinator: Clinical Trial Manage
• Email: gil.gonen-yaacovi@weizmann.ac.il
• Phone: +972522666230

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.