Clinical trial · Observational

Replacing Bone Marrow Diagnostics With Peripheral Blood Analysis in MPN Patients

Development of a Peripheral Blood Assay to Replace Bone Marrow Biopsy in Myeloproliferative Neoplasms- a Multi-center Observational Study

NCT07648433CI-TRIAL-00124898not yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Myeloproliferative Neoplasm	Myeloproliferative Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
PERIBLOOD-MPN	Diagnostic Test	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
To development PERIBLOOD-MPN Diagnostic Test
timeFrame
Three months following the PB sample
description
Development of PERIBLOOD-MPN Diagnostic Test Using PB-Derived CD34+ cHSPCs for Diagnosis of MPN

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

1. Age ≥ 18 years
2. 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
3. Patients who are referred for a bone marrow biopsy due to a suspected diagnosis of MPN

Exclusion Criteria:

1. Patients diagnosed with MPN receiving therapy
2. Patients who have undergone a bone marrow transplant

References

Publications (0)

Data not yet available

No reference posted for this study.