Multi-Center Clinical Trial to Replace BM Analysis of Cytopenia by a Peripheral Blood Assay

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

This study aims to validate a novel, non-invasive diagnostic approach for blood and bone marrow malignancies using single-cell RNA sequencing of circulating hematopoietic stem and progenitor cells (cHSPCs) from peripheral blood. Building on prior work defining normal cHSPC profiles in healthy individuals, the study introduces a pipeline for identifying blood pathologies, with a focus on improving the diagnosis and subclassification of myelodysplastic syndromes (MDS). A multi-center clinical trial is proposed to evaluate the method's ability to predict bone marrow results in patients with cytopenia, potentially reducing reliance on bone marrow biopsies.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Platelets \< 150 × 109/L or

• Absolute neutrophil count \< 1.8 × 109/L or

• Hemoglobin (Hgb) \< 13 g/dL (males) and \< 12 g/dL (female) and

• For all genders, no evidence of Iron, folinic acid, or B12 deficiency

• All subjects should be referred for BM analysis

Locations
United States
Florida
University of Miami
RECRUITING
Miami
Contact Information
Primary
Clinical Trial Manage
gil.gonen-yaacovi@weizmann.ac.il
+972522666230
Backup
Liran Shlush, Prof.
liran.shlush@weizmann.ac.il
+972505109815
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2028-12
Participants
Target number of participants: 1500
Treatments
PERIBLOOD
Related Therapeutic Areas
Sponsors
Leads: Weizmann Institute of Science

This content was sourced from clinicaltrials.gov