Replacing Bone Marrow Diagnostics With Peripheral Blood A... | NCT07081087

Studies
Replacing Bone Marrow Diagnostics With Peripheral Blood Analysis in Cytopenia Patients

NCT07081087

Sponsor

Weizmann Institute of Science

Status

Recruiting

Last Update Posted

Mar 25, 2026Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Cytopenia
MDS

Interventions

PERIBLOOD-MDS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2025Actual

Primary Completion Date

Dec 2028Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

Jul 15, 2025

First Submission Date that Met QC Criteria

Jul 15, 2025

First Posted Date

Jul 23, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2026

Last Update Posted Date

Mar 25, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

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. Current MDS diagnosis relies on bone marrow (BM) aspiration and biopsy, which is invasive, technically challenging, and sometimes inconclusive, particularly in early or low-risk disease. Our prior research established a healthy reference map of cHSPC subtypes and developed a computational pipeline that distinguishes MDS from non-clonal cytopenias based on deviations from this reference. In this study, patients referred, as part of standard care, for BM evaluation due to unexplained cytopenias or abnormal blood counts and undergo PB collection for genomic profiling. The study's primary objective is to develop a PB-based test by comparing the developed test diagnoses to the conventional BM-based one. Secondary objectives include evaluating its potential for MDS risk stratification and assessing its ability to reduce the need for BM evaluations.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PERIBLOOD-MDS		No intervention is given	Diagnostic Test: PERIBLOOD-MDS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clinical Trial Manage	Contact	+972522666230		gil.gonen-yaacovi@weizmann.ac.il
Liran Shlush, Prof.	Contact	+972505109815		liran.shlush@weizmann.ac.il

Overall Officials

Name	Affiliation	Role
Liran Shlush	The Weizmann Institute of Science	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California San Diego	Recruiting	San Diego	California	92093	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000095542	Cytopenia

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided