Drug Observance and Side Effects of Cytoreductive Drugs in PV and ET Patients

NCT ID: NCT02893410

Last Updated: 2018-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

286 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-12-31

Brief Summary

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Patients treated with oral or sub-cutaneous drugs for polycythemia vera or essential thrombocythemia completed an unique paper questionnaire in order to describe their observance, the side effects and their own appreciation of the taken drug.

Detailed Description

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During one year, all patients with PV or ET followed in our centre, and who took a drug to treat their MPN, were identified.

The investigators submitted by mail or directly at the consultation a unique questionnaire containing 25 questions concerning patients characteristics, evaluation of observance, identification of side effects and own appreciation of the drug.

After completion of the questionnaire, the patients were identified and followed to collect new data about thrombotic events or phenotypic evolution.

Conditions

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Polycythemia Vera Essential Thrombocythemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with PV or ET or SMF
* Patients who took oral or sub-cutaneous drugs to treat their MPN.
* Patients who agreed to complete the questionnaire

Exclusion Criteria

* Patients with low risk PV or ET who do not take treatment
* Patients unable to complete the questionnaire
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Christophe Ianotto, MD

Role: STUDY_DIRECTOR

CHRU de Brest

Locations

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CHRU de Brest

Brest, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 29246923 (View on PubMed)

Other Identifiers

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OUEST (RB14.115)

Identifier Type: -

Identifier Source: org_study_id

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