NCT02897297

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...).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

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 Start

First participant enrolled

September 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

10.1 years

First QC Date

August 26, 2016

Last Update Submit

August 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    occurrence of death

    10 years

Secondary Outcomes (2)

  • Incidence of evolutions

    10 years

  • Incidence of thromboses

    10 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients followed for essentiel thrombocythemia, polycythemia vera or primary myelofibrosis

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

RECRUITING

Related Publications (10)

  • Delluc A, Lacut K, Pan-Petesch B, Galinat H, Lippert E, Ianotto JC. Statin exposure and thrombosis risk in patients with myeloproliferative neoplasms. Thromb Res. 2018 Jul;167:57-59. doi: 10.1016/j.thromres.2018.05.014. Epub 2018 May 16. No abstract available.

  • Mollard LM, Chauveau A, Boyer-Perrard F, Douet-Guilbert N, Houot R, Quintin-Roue I, Couturier MA, Dagorne A, Malou M, Le Calloch R, Luycx O, Thepot S, Hunault M, Guillerm G, Berthou C, Ugo V, Lippert E, Ianotto JC. Outcome of Ph negative myeloproliferative neoplasms transforming to accelerated or leukemic phase. Leuk Lymphoma. 2018 Dec;59(12):2812-2820. doi: 10.1080/10428194.2018.1441408. Epub 2018 Apr 4.

  • Mansier O, Luque Paz D, Ianotto JC, Le Bris Y, Chauveau A, Boyer F, Conejero C, Fitoussi O, Riou J, Adiko D, Touati M, Chauzeix J, Viallard JF, Bene MC, Giraudier S, Ugo V, Lippert E. Clinical and biological characterization of MPN patients harboring two driver mutations, a French intergroup of myeloproliferative neoplasms (FIM) study. Am J Hematol. 2018 Aug;93(4):E84-E86. doi: 10.1002/ajh.25014. Epub 2018 Jan 12. No abstract available.

  • Le Calloch R, Lacut K, Le Gall-Ianotto C, Nowak E, Abiven M, Tempescul A, Dalbies F, Eveillard JR, Ugo V, Giraudier S, Guillerm G, Lippert E, Berthou C, Ianotto JC. Non-adherence to treatment with cytoreductive and/or antithrombotic drugs is frequent and associated with an increased risk of complications in patients with polycythemia vera or essential thrombocythemia (OUEST study). Haematologica. 2018 Apr;103(4):607-613. doi: 10.3324/haematol.2017.180448. Epub 2017 Dec 15.

  • Ianotto JC, Chauveau A, Boyer-Perrard F, Gyan E, Laribi K, Cony-Makhoul P, Demory JL, de Renzis B, Dosquet C, Rey J, Roy L, Dupriez B, Knoops L, Legros L, Malou M, Hutin P, Ranta D, Benbrahim O, Ugo V, Lippert E, Kiladjian JJ. Benefits and pitfalls of pegylated interferon-alpha2a therapy in patients with myeloproliferative neoplasm-associated myelofibrosis: a French Intergroup of Myeloproliferative neoplasms (FIM) study. Haematologica. 2018 Mar;103(3):438-446. doi: 10.3324/haematol.2017.181297. Epub 2017 Dec 7.

  • Mahe K, Delluc A, Chauveau A, Castellant P, Mottier D, Dalbies F, Berthou C, Guillerm G, Lippert E, Ianotto JC. Incidence and impact of atrial arrhythmias on thrombotic events in MPNs. Ann Hematol. 2018 Jan;97(1):101-107. doi: 10.1007/s00277-017-3164-x. Epub 2017 Nov 21.

  • Ianotto JC, Couturier MA, Galinat H, Mottier D, Berthou C, Guillerm G, Lippert E, Delluc A. Administration of direct oral anticoagulants in patients with myeloproliferative neoplasms. Int J Hematol. 2017 Oct;106(4):517-521. doi: 10.1007/s12185-017-2282-5. Epub 2017 Jun 16.

  • Le Clech L, Sakka M, Meskar A, Kerspern H, Eveillard JR, Berthou C, Buors C, Lippert E, Guillerm G, Quintin-Roue I, Carre JL, Ianotto JC. The presence of monoclonal gammopathy in Ph-negative myeloproliferative neoplasms is associated with a detrimental effect on outcomes. Leuk Lymphoma. 2017 Nov;58(11):2582-2587. doi: 10.1080/10428194.2017.1312380. Epub 2017 May 9.

  • Le Gall-Ianotto C, Brenaut E, Gouillou M, Lacut K, Nowak E, Tempescul A, Berthou C, Ugo V, Carre JL, Misery L, Ianotto JC. Clinical characteristics of aquagenic pruritus in patients with myeloproliferative neoplasms. Br J Dermatol. 2017 Jan;176(1):255-258. doi: 10.1111/bjd.14809. Epub 2016 Dec 22. No abstract available.

  • Gall-Ianotto CL, Civi L, Pan-Petesch B, Herbreteau L, Rio L, Lambert WC, Misery L, Lippert E, Ianotto JC. Ruxolitinib and Hydroxycarbamide Are the Most Efficient Drugs to Reduce Aquagenic Pruritus Intensity in a Real-Word Cohort of Patients With Myeloproliferative Neoplasms. EJHaem. 2025 Dec 11;6(6):e70197. doi: 10.1002/jha2.70197. eCollection 2025 Dec.

MeSH Terms

Conditions

Polycythemia VeraThrombocythemia, EssentialPrimary Myelofibrosis

Condition Hierarchy (Ancestors)

Bone Marrow NeoplasmsHematologic NeoplasmsNeoplasms by SiteNeoplasmsBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesMyeloproliferative DisordersBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersHemorrhagic Disorders

Study Officials

  • Jean-Christophe Ianotto

    CHRU de Brest

    STUDY DIRECTOR

Central Study Contacts

Jean-Christophe Ianotto

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 26, 2016

First Posted

September 13, 2016

Study Start

September 1, 2015

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

August 12, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations