NCT07204392

Brief Summary

The classic Ph-negative myeloproliferative neoplasms (MPN) are a group of clonal hematopoietic disorders caused by a dysregulated JAK/STAT signal transduction because of acquired somatic mutations of JAK2, CALR or MPL genes. They are sporadic diseases but there are several lines of evidence that support the role of germline factors in the pathogenesis of MPN: the existence of familial clustering, the presence of more than one clone in some patients, the known existence of common polymorphisms that cause predisposition to MPN. In this study, we would like to define the germline predisposition to MPN.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
313

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jun 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Jun 2022Dec 2030

Study Start

First participant enrolled

June 27, 2022

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

8.5 years

First QC Date

September 24, 2025

Last Update Submit

September 24, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • To identify a germline predisposition to MPN through the application of an NGS-based gene panel test in young patients.

    3 years

  • To identify the germline genetic factors that underlie familial clustering of MPN through whole genome sequencing (WGS).

    3 years

Secondary Outcomes (1)

  • To identify phenotype-genotype correlations: we aim to correlate the molecular data with clinical data and relevant outcomes

    3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients affected with early-onset or familial myeloproliferative

You may qualify if:

  • A diagnosis of PV, ET, prePMF, overt PMF or MPN-U according to 2016 WHO criteria
  • Characterization of the MPN driver mutation performed at any moment before enrolment
  • diagnosis of MPN made when the patient was younger than 27 years old OR at least a second case of hematologic malignancies in first or second-degree relatives

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Myeloproliferative Disorders

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 24, 2025

First Posted

October 2, 2025

Study Start

June 27, 2022

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations