NCT02893410

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
286

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
Last Updated

September 21, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

August 26, 2016

Last Update Submit

September 20, 2018

Conditions

Polycythemia VeraEssential Thrombocythemia

Outcome Measures

Primary Outcomes (1)

  • Rate of adherence to drug prescription

    prospective evaluation in a one shot questionnaire given to each treated patient seen at the consultation distributed between december 2014 and december 2015

    At inclusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with PV or ET who took oral or sub-cutaneous drugs to treat MPN disorders.

You may qualify if:

  • 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

You may not qualify if:

  • Patients with low risk PV or ET who do not take treatment
  • Patients unable to complete the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

Related Publications (1)

  • 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.

    PMID: 29246923RESULT

MeSH Terms

Conditions

Polycythemia VeraThrombocythemia, Essential

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, MD

    CHRU de Brest

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 26, 2016

First Posted

September 8, 2016

Study Start

December 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 21, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)