Replacing Bone Marrow Diagnostics With Peripheral Blood Analysis in MDS/Cytopenia Patients

NCT ID: NCT07081087

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2028-12-31

Brief 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.

Conditions

Cytopenia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

PERIBLOOD

PERIBLOOD

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

PERIBLOOD

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Previous diagnosis of leukemia (AML, MPN, ALL, CLL, MGUS/MM or any other gammopathy)
• Lymphocytes>5000/ul
• If patients are recruited after
• Diagnosis of any disease related therapy 3 month prior to enrollment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weizmann Institute of Science

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of California San Diego

San Diego, California, United States

Site Status: RECRUITING

University of Miami

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Trial Manage

Role: CONTACT

gil.gonen-yaacovi@weizmann.ac.il

+972522666230

Liran Shlush, Prof.

Role: CONTACT

liran.shlush@weizmann.ac.il

+972505109815

Facility Contacts

Tan Tuyet

Role: primary

Helen Kattoura, Dr.

Role: primary

305-243-6438

Other Identifiers

PERIBLODD-MDS

Identifier Type: -

Identifier Source: org_study_id