Children, Adolescents and Young Adults with Myeloproliferative Neoplasia: Study of Clinico-biological Characteristics and Complications (VYP) (VYP)

Children, Adolescents and Young Adults with Myeloproliferative Neoplasia: Study of Clinico-biological Characteristics and Complications

The creation of a national database will provide access to solid data on the diagnosis of myeloproliferative neoplasia for patients under 30, giving a true picture of their care. It will also make it possible to identify the biological samples (histological and molecular) available in routine laboratories, enabling teams of researchers and anatomopathologists to (re)perform certain analyses to re-evaluate diagnoses and search for hitherto unknown molecular prognostic factors.

Study Overview

• Status: Recruiting
• Conditions: Myeloproliferative Neoplasm

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Jean-Christophe IANOTTO; Phone Number: +33 0298223786; Email: jean-christophe.ianotto@chu-brest.fr

Study Locations

• France
  • Brest, France, 29609
    • Recruiting
    • CHU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with non-LMC myeloproliferative neoplasm before age 30 (Polycythemia vera, essential thrombocythemia, primary myelofibrosis, prefibrotic myelofibrosis).

Description

Inclusion Criteria:

• Patient diagnosed with non-LMC MPN before the age of 30 (PV or TE or MFP or PreMF) according to the 2016 WHO criteria.
• Signature of the consent form for participation in the FIMBANK project.
• Agreement to participate in the VYP study.
• Patient of legal age at the time of inclusion in VYP.
• Patient affiliated to a social security scheme

Exclusion Criteria:

• Refusal to participate by patients of full age
• Patient under legal protection (guardianship, curatorship, etc.)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe the epidemiological characteristics of the study population	Description of MPN subtypes according to age	at enrollment
Describe the mutational landscape of these MPNs	Rate of mutations JAK2/CALR/MPL	at enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe the classical MPN (Myeloproliferative neoplasia) outcomes-1	Incidence of thrombosis	At 10 years
Describe the classical MPN outcomes-2	Incidence of myelofibrosis	At 10 years
Describe the classical MPN outcomes-3	Incidence of MDS/AML	At 10 years

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): April 1, 2038
• Study Completion (Estimated): April 1, 2038

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 4, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Bone Marrow Diseases; Myeloproliferative Disorders
• Other Study ID Numbers: 29BRC23.0018 - VYP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No