Myeloproliferative NeoplasmNCT07648433
Replacing Bone Marrow Diagnostics With Peripheral Blood Analysis in MPN Patients
An observational study of Myeloproliferative Neoplasm, run by Weizmann Institute of Science.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasm
- What is being tested?
- PERIBLOOD-MPN
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jun 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with MPN, or suspicion for MPN, who are referred to BM will be recruited to the study
Who may be able to join
- 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)
Show all 15Show fewer
- 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
Who cannot join
- Patients diagnosed with MPN receiving therapy
- Patients who have undergone a bone marrow transplant
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development of a Peripheral Blood Assay to Replace Bone Marrow Biopsy in Myeloproliferative Neoplasms- a Multi-center Observational Study
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.
Read the detailed description
PERIBLOOD-MPN is an observational, multi-center study that aims to collect data to develop a novel, minimally invasive diagnostic tool for myeloproliferative neoplasms (MPN) based on peripheral blood (PB) profiling of circulating hematopoietic stem and progenitor cells (cHSPCs) using single-cell RNA sequencing (scRNA-seq). Current diagnostic practice relies on bone marrow (BM) biopsy, a procedure that is invasive, technically demanding, and may be inconclusive in early or prefibrotic disease stages.
Prior work in the field has established a reference atlas of healthy cHSPC subtypes and a computational pipeline capable of identifying disease-specific transcriptional changes by quantifying deviations from this reference. This study will assess whether PB-based genomic profiling can accurately distinguish MPN from non-clonal cytoses, including secondary erythrocytosis or thrombocytosis.
Patients referred for a bone marrow biopsy due to suspected myeloproliferative neoplasm (MPN) will undergo PB collection for genomic profiling. The primary objective is to develop a PB-based test by comparing the new test's diagnoses to conventional BM-based diagnostics. The secondary objectives include evaluating its potential for MPN subtype classification and risk stratification, as well as assessing its ability to reduce the need for BM biopsies.
- Conditions
- Myeloproliferative Neoplasm
- Being tested
- PERIBLOOD-MPN
- Medical subject headings
- Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PERIBLOOD-MPNDiagnostic test
Observational intervation of cHSPCs
What is being measured
The primary outcome is the main question the study is designed to answer.
To development PERIBLOOD-MPN Diagnostic Test
Development of PERIBLOOD-MPN Diagnostic Test Using PB-Derived CD34+ cHSPCs for Diagnosis of MPN
Measured: Three months following the PB sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weizmann Institute of Science
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648433
- Sponsor's protocol ID
- PERIBLOOD-MPN
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We will send PERIBLOOD report including the genetic data, for each patients, to the participating sites
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Peripheral Blood Assay to Replace Bone Marrow Biopsy in Myeloproliferative Neoplasms- a Multi-center Observational Study
- ClinicalTrials.gov ID
- NCT07648433
- Acronym / sponsor ID
- PERIBLOOD-MPN
- Conditions
- Myeloproliferative Neoplasm
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Weizmann Institute of ScienceUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PERIBLOOD-MPN is an observational, multi-center study that aims to collect data to develop a novel, minimally invasive diagnostic tool for myeloproliferative neoplasms (MPN) based on peripheral blood (PB) profiling of circulating hematopoietic stem and progenitor cells (cHSPCs) using single-cell RNA sequencing (scRNA-seq). Current diagnostic practice relies on bone marrow (BM) biopsy, a procedure that is invasive, technically demanding, and may be inconclusive in early or prefibrotic disease stages.
Prior work in the field has established a reference atlas of healthy cHSPC subtypes and a computational pipeline capable of identifying disease-specific transcriptional changes by quantifying deviations from this reference. This study will assess whether PB-based genomic profiling can accurately distinguish MPN from non-clonal cytoses, including secondary erythrocytosis or thrombocytosis.
Patients referred for a bone marrow biopsy due to suspected myeloproliferative neoplasm (MPN) will undergo PB collection for genomic profiling. The primary objective is to develop a PB-based test by comparing the new test's diagnoses to conventional BM-based diagnostics. The secondary objectives include evaluating its potential for MPN subtype classification and risk stratification, as well as assessing its ability to reduce the need for BM biopsies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with MPN, or suspicion for MPN, who are referred to BM will be recruited to the study
Key inclusion criteria (15 listed)
- Age ≥ 18 years
- Confirmed MPN diagnosis, based on the WHO criteria (Barbui 2018), which includes:
- Patients who are referred for a bone marrow biopsy due to a suspected diagnosis of MPN
Key exclusion criteria (2 listed)
- Patients diagnosed with MPN receiving therapy
- Patients who have undergone a bone marrow transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PERIBLOOD-MPNObservational intervation of cHSPCs | Diagnostic test | – |
Primary outcome
To development PERIBLOOD-MPN Diagnostic Test
Time frame: Three months following the PB sample
Development of PERIBLOOD-MPN Diagnostic Test Using PB-Derived CD34+ cHSPCs for Diagnosis of MPN
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No. We will send PERIBLOOD report including the genetic data, for each patients, to the participating sites
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloproliferative Neoplasm, run by Weizmann Institute of Science.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liran Shlush, Prof. (+97289342247, liran.shlush@weizmann.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To development PERIBLOOD-MPN Diagnostic Test (time frame: Three months following the PB sample). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.