Replacing Bone Marrow Diagnostics With Peripheral Blood Analysis in Cytopenia Patients

NCT07081087 | Recruiting FDA Device

• 1 other identifier: PERIBLODD-MDS
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

MDS; Cytopenia

Outcome Measures

Primary Outcomes (1)

• To develop PERIBLOOD-MDS diagnostic test of PB cHPCs for the diagnosis of MDS

  Comparison between PERIBLOOD-MDS diagnosis and bone marrow evaluation of MDS

  Three months following the peripheral blood sample

Study Arms (1)

PERIBLOOD-MDS

No intervention is given

Diagnostic Test: PERIBLOOD-MDS

Interventions

PERIBLOOD-MDS 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

PERIBLOOD-MDS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cytopenia, who are referred to BM from the primary care clinic will be recruited to the study

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weizmann Institute of Science: lead

Study Sites (2)

University of California San Diego

San Diego, California, 92093, United States

RECRUITING

University of Miami

Miami, Florida, 33146, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood sample

MeSH Terms

Conditions

Cytopenia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Liran Shlush

  The Weizmann Institute of Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trial Manage

CONTACT

+972522666230; gil.gonen-yaacovi@weizmann.ac.il

Liran Shlush, Prof.

CONTACT

+972505109815; liran.shlush@weizmann.ac.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 23, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 25, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)