Myeloproliferative Neoplastic Diseases Observatory From Brest (OBENE)

June 27, 2019 updated by: University Hospital, Brest

Observatoire Brestois Des Néoplasies Myéloprolifératives

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...).

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Brest, France, 29609
        • Recruiting
        • CHRU de Brest
        • Contact:
          • Jean-Christophe Ianotto, MD
        • Contact:
          • Eric Lippert, MD-PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients followed for essentiel thrombocythemia, polycythemia vera or primary myelofibrosis

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 10 years
occurrence of death
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of evolutions
Time Frame: 10 years
occurrence of transformation into polycythemia vera, secondary myelofibrosis, myelodysplastic syndrome or acute leukemia
10 years
Incidence of thromboses
Time Frame: 10 years
occurrence of arterial or venous thrombotic events
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Study Director: Jean-Christophe Ianotto, CHRU de Brest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

September 1, 2025

Study Completion (Anticipated)

September 1, 2025

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimate)

September 13, 2016

Study Record Updates

Last Update Posted (Actual)

July 1, 2019

Last Update Submitted That Met QC Criteria

June 27, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBENE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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