Replacing Bone Marrow Diagnostics With Peripheral Blood Analysis in Cytopenia Patients
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.
| Condition(s) | Cytopenia, MDS |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Weizmann Institute of Science |
| Locations | San Diego, California, United States; Miami, Florida, United States |
| Start date | 2025-06-01 |
| NCT ID | NCT07081087 |
| Official listing | https://clinicaltrials.gov/study/NCT07081087 |