Replacing Bone Marrow Diagnostics With Peripheral Blood Analysis in MPN Patients

NCT07648433 | Not Yet Recruiting FDA Device

• 1 other identifier: PERIBLOOD-MPN
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The PERIBLOOD-MPN study aims to develop and validate a minimally invasive peripheral blood test using single-cell RNA sequencing to accurately diagnose and classify myeloproliferative neoplasms, potentially reducing the need for invasive bone marrow biopsies.

Conditions

Myeloproliferative Neoplasm

Outcome Measures

Primary Outcomes (1)

• To development PERIBLOOD-MPN Diagnostic Test

  Development of PERIBLOOD-MPN Diagnostic Test Using PB-Derived CD34+ cHSPCs for Diagnosis of MPN

  Three months following the PB sample

Interventions

PERIBLOOD-MPN DIAGNOSTIC_TEST

Observational intervation of cHSPCs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with MPN, or suspicion for MPN, who are referred to BM will be recruited to the study

You may qualify if:

• Age ≥ 18 years
• Confirmed MPN diagnosis, based on the WHO criteria (Barbui 2018), which includes:
• Polycythemia Vera (PV) Criteria:
• Elevated hemoglobin (\>16.5 g/dL for men, \>16.0 g/dL for women), hematocrit (\>49% for men, \>48% for women), or increased red cell mass
• Bone marrow biopsy showing hypercellularity with trilineage growth (panmyelosis)
• Presence of JAK2 mutation (V617F or exon 12)
• Essential Thrombocythemia (ET) Criteria:
• Platelet count ≥450 ×10⁹/L
• Bone marrow biopsy showing proliferation mainly of the megakaryocyte lineage
• Not meeting WHO criteria (Alaggio et al., 2022) for other myeloid neoplasms (such as CML, PV, PMF, MDS).
• Presence of JAK2, CALR, or MPL mutation Primary Myelofibrosis (PMF) Criteria
• Megakaryocytic proliferation and atypia, with or without reticulin fibrosis, and increased marrow cellularity (for prefibrotic/early PMF) or significant reticulin/collagen fibrosis (for overt PMF)
• Not meeting criteria for other myeloid neoplasms
• Presence of JAK2, CALR, or MPL mutation, or in their absence, another clonal marker
• Patients who are referred for a bone marrow biopsy due to a suspected diagnosis of MPN

You may not qualify if:

• Patients diagnosed with MPN receiving therapy
• Patients who have undergone a bone marrow transplant

Sponsors & Collaborators

• Weizmann Institute of Science: lead

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples

MeSH Terms

Conditions

Myeloproliferative Disorders

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Liran Shlush, Prof.

CONTACT

+97289342247; liran.shlush@weizmann.ac.il

Gil Gonen Yaacovi, PhD

CONTACT

+9728747027401; gil.gonen-yaacovi@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: June 9, 2026
• First Posted: June 15, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2032
• Last Updated: September 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share