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Myeloproliferative Neoplastic Diseases Observatory From Brest (OBENE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02897297
Recruitment Status : Recruiting
First Posted : September 13, 2016
Last Update Posted : January 17, 2018
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:

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

MPNs recorded included: polycythemia vera (PV), essential Thrombocythemia (ET) and Primary Myelofibrosis (PMF).

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...).

Condition or disease
Polycythemia Vera Essential Thrombocythemia Primary Myelofibrosis

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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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Observatoire Brestois Des Néoplasies Myéloprolifératives
Study Start Date : September 2015
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: twenty years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients followed for PV, ET or PMF

Inclusion Criteria:

  • Patients with ET or PV or PMF
  • Signature of the non-opposition consent form

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02897297

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Contact: Jean-Christophe Ianotto

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CHRU de Brest Recruiting
Brest, France, 29609
Contact: Jean-Christophe Ianotto, MD         
Contact: Eric Lippert, MD-PhD         
Sponsors and Collaborators
University Hospital, Brest
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Study Director: Jean-Christophe Ianotto CHRU de Brest

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital, Brest Identifier: NCT02897297     History of Changes
Other Study ID Numbers: OBENE
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Primary Myelofibrosis
Polycythemia Vera
Thrombocythemia, Essential
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders