Myeloproliferative Neoplastic Diseases Observatory From Brest

Recruiting

• Conditions: Polycythemia Vera; Essential Thrombocythemia; Primary Myelofibrosis

• Registration Number: NCT02897297
• Lead Sponsor: University Hospital, Brest

Brief Summary

All patients diagnosed or followed in Brest University Hospital for Philadelphia negative myeloproliferative neoplasms will be included in this observational study.

Myeloproliferative neoplasms recorded included: polycythemia vera, essential Thrombocythemia and Primary Myelofibrosis.

This is a not interventional study. Alive patients need to sign a non-opposition consent form.

Patients will be followed until last news (death, change of reference centre...).

Detailed Description

In this retrospective and prospective study, clinical and biological data from diagnosis until last news will be recorded.

Clinical data collected: patients and disease characteristics at the time of the diagnosis, disease and mutational status, cardio-vascular risk factors, history of thrombosis and cancer.

Biological data collected: hemogram and bone marrow results if available. During the follow-up new data will be noted: treatment changes (reasons of change and type of drug), thrombotic events (localization, date and hemogram), phenotypic evolutions (type and date), death (date and etiology).

Study Timeline

• Study Start: 2015-09-01
• Study First Submitted: 2016-08-26
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Patients with essentiel thrombocythemia, polycythemia vera or primary myelofibrosis
• Signature of the non-opposition consent form

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival	10 years	occurrence of death

Secondary Outcome Measures

Name	Time	Method
Incidence of evolutions	10 years	occurrence of transformation into polycythemia vera, secondary myelofibrosis, myelodysplastic syndrome or acute leukemia
Incidence of thromboses	10 years	occurrence of arterial or venous thrombotic events

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France