Recruiting

Blood Malignancies

Sponsor:

Weizmann Institute of Science

Code:

NCT07081087

Conditions

Cytopenia

MDS

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PERIBLOOD-MDS

Study Details

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

Cytopenia

MDS

Study ID

NCT07081087

Start date

Jun 1, 2025

Status verified date

Sep, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

PERIBLOOD-MDS

No intervention is given

Interventions

PERIBLOOD-MDS

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

Primary outcome measure

  • To develop PERIBLOOD-MDS diagnostic test of PB cHPCs for the diagnosis of MDS [ Time Frame: Three months following the peripheral blood sample ]

Central Contacts and Locations

Central contacts

Clinical Trial Manage

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

Liran Shlush, Prof.

+972505109815liran.shlush@weizmann.ac.il

Locations

University of California San Diego

Recruiting

San Diego, California, United States, 92093

Principal Investigator:

Rafael Bejar

University of Miami

Recruiting

Miami, Florida, United States, 33146

Contacts

Helen Kattoura, Dr.

305-243-6438

Principal Investigator:

Stephen Nimer

More Information

Sponsor

Weizmann Institute of Science

Last update posted

Mar 25, 2026

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Weizmann Institute of Science on 2026-03-25.