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RecruitingNCT02897297OBENEUpdated Aug 12, 2024

Myeloproliferative Neoplastic Diseases Observatory From Brest

An observational study in Polycythemia Vera, Essential Thrombocythemia and Primary Myelofibrosis, sponsored by University Hospital, Brest. Recruiting at 1 site in France. Per ClinicalTrials.gov, last updated 2024-08-12.

Sponsored by University Hospital, Brest · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Sep 2015; still recruiting 11 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
1,000
Sex
All
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Study 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...).

Read the 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).

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Conditions studied

  • Polycythemia Vera
  • Essential Thrombocythemia
  • Primary Myelofibrosis
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In context

Polycythemia Vera

278 studies on the registry are indexed under Polycythemia Vera; 53 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 240 across 44 observational studies indexed under Polycythemia Vera.

Browse Polycythemia Vera studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients followed for essentiel thrombocythemia, polycythemia vera or primary myelofibrosis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
1,000 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Overall Survival

    occurrence of death

    Time frame: 10 years

Secondary outcomes

  1. Incidence of evolutions

    occurrence of transformation into polycythemia vera, secondary myelofibrosis, myelodysplastic syndrome or acute leukemia

    Time frame: 10 years

  2. Incidence of thromboses

    occurrence of arterial or venous thrombotic events

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 29787944 ↗
  • 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. PubMed 29616837 ↗
  • 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. PubMed 29266414 ↗
  • 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. PubMed 29246923 ↗
  • 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. PubMed 29217781 ↗
  • 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. PubMed 29164292 ↗
  • 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. PubMed 28623609 ↗
  • 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. PubMed 28482711 ↗
  • 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. PubMed 27291777 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2015 (actual). Primary completion is estimated for Sep 2025, 120 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2016
First posted
Sep 13, 2016
StartActual
Sep 1, 2015
Primary completionEst.
Sep 30, 2025
CompletionEst.
Sep 30, 2025
Last update
Aug 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02897297
Responsible party
Sponsor
First posted
Sep 13, 2016
Start date
Sep 1, 2015
Primary completion
Sep 30, 2025 (estimated)
Completion
Sep 30, 2025 (estimated)
Last update
Aug 12, 2024

Study contacts

Jean-Christophe Ianotto
Contact
jean-christophe.Ianotto@chu-brest.fr
Jean-Christophe Ianotto
study director · CHRU de Brest

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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