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

NCT06715267 | Recruiting

• 1 other identifier: 29BRC23.0018 - VYP
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myeloproliferative Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Describe the classical MPN (Myeloproliferative neoplasia) outcomes-1

  At 10 years

• Describe the classical MPN outcomes-2

  At 10 years

• Describe the classical MPN outcomes-3

  At 10 years

Eligibility Criteria

• Age: 0 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• 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 affiliated to a social security scheme

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHU de Brest

Brest, 29609, France

RECRUITING

MeSH Terms

Conditions

Myeloproliferative Disorders

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Jean-Christophe IANOTTO

CONTACT

0298223786; jean-christophe.ianotto@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: December 4, 2024
• Study Start: April 1, 2023
• Primary Completion (Estimated): April 1, 2038
• Study Completion (Estimated): April 1, 2038
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• 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.

Locations

FR (1)