NCT03688490

Brief Summary

Description of the characteristics of aquagenic pruritus expressed by patients suffering from myeloproliferative neoplasms. Prospective work based on the distribution of a dedicated questionnaire.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2013

Shorter than P25 for all trials

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

July 17, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2013

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
Last Updated

July 1, 2019

Status Verified

August 1, 2018

Enrollment Period

4 months

First QC Date

September 20, 2018

Last Update Submit

June 27, 2019

Conditions

Myeloproliferative Disorder

Keywords

aquagenic pruritus

Outcome Measures

Primary Outcomes (1)

  • Intensity of the pruritus

    Analogic Visual Scale, from 0 to 10, Worse if \>6

    15 days

Secondary Outcomes (1)

  • Duration of the pruritus

    15 days

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients followed for myeloproliferative neoplasms in our Institution (Brest University Hospital)

You may qualify if:

  • patients followed with myeloproliferative neoplasms
  • suffering from aquagenic pruritus

You may not qualify if:

  • Unable to fulfil the questionnaire
  • No written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27291777RESULT

MeSH Terms

Conditions

Myeloproliferative Disorders

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • IANOTTO Jean-Christophe, MD, PhD

    Hématologie Clinique-Institut de Cancéro-Hématologie

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 20, 2018

First Posted

September 28, 2018

Study Start

July 17, 2013

Primary Completion

November 4, 2013

Study Completion

November 4, 2013

Last Updated

July 1, 2019

Record last verified: 2018-08