Aquagenic Pruritus in Myeloproliferative Neoplasms (PANAM)

August 7, 2019 updated by: University Hospital, Brest

Description of the characteristics of aquagenic pruritus expressed by patients suffering from myeloproliferative neoplasms.

Prospective work based on the distribution of a dedicated questionnaire.

Study Overview

Status

Unknown

Conditions

Detailed Description

Patients with myeloproliferative neoplasms identified and followed in French Hospitals. Patients could be followed for polycythemia vera or essential thrombocythemia or primary myelofibrosis.

Distribution of the questionnaire to each patient with myeloproliferative neoplasm (treated or not) suffering from aquagenic pruritus.

Analyse of each characteristic of the aquagenic pruritus by a statistician and publication at the end.

Study Type

Observational

Enrollment (Anticipated)

125

Contacts and Locations

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

Study Locations

  • France
    • Auvergne Rhônes-alpes
    • Brestagne
      • Quimper, Brestagne, France, 29000
    • Bretagne
      • Morlaix, Bretagne, France, 29600
        • Not yet recruiting
        • 11
        • Contact:
          • Mohamed MALOU
          • Phone Number: +33298791297
      • Saint-Brieuc, Bretagne, France, 22000
    • Grand Est
      • Saint-Louis, Grand Est, France, 68300
    • Haute-Savoie
    • Hauts-de-France
      • Roubaix, Hauts-de-France, France, 59100
    • Nouvelle Aquitaine
      • Rochefort, Nouvelle Aquitaine, France, 17300
    • Pays De La Loire
      • Angers, Pays De La Loire, France, 49000
    • Val-de-marne
      • Villejuif, Val-de-marne, France, 94800

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with one of three Philadelphia positive non-chromosome myeloproliferative neoplasms: polycythemia vera (PV), essential thrombocythemia (TE) or primary myelofibrosis (PMF).

And suffering (or having suffered) from aquagenic pruritus.

Description

Inclusion Criteria:

  • Patients with one of three non-chromosomal Philadelphia-positive myeloproliferative neoplasms: polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF).
  • Suffering (or having suffered) from aquagenic pruritus.
  • No age limit, but major
  • Patient having formulated his non-opposition

Exclusion Criteria:

  • Patients with MPN with non-aquagenic pruritus,
  • Patients with another hematologic disease and aquagenic pruritus
  • Patients unable to complete the questionnaire.
  • Patients with physical or mental disabilities to formulate non-opposition
  • Refusal of participation

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: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of pruritus in patients with myeloproliferative neoplasms
Time Frame: at the time of questionnaire completion (Day 0)
Intensity of pruritus (visual analogic scale)
at the time of questionnaire completion (Day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of therapies used to treat pruritus
Time Frame: at the time of questionnaire completion (Day 0)
Name of drugs used
at the time of questionnaire completion (Day 0)

Collaborators and Investigators

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

Sponsor

University Hospital, Brest

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 (Actual)

July 9, 2019

Primary Completion (Anticipated)

January 9, 2020

Study Completion (Anticipated)

January 9, 2020

Study Registration Dates

First Submitted

May 24, 2019

First Submitted That Met QC Criteria

July 10, 2019

First Posted (Actual)

July 12, 2019

Study Record Updates

Last Update Posted (Actual)

August 9, 2019

Last Update Submitted That Met QC Criteria

August 7, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANAM (29BRC19.0001)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning six months and ending five years following the publication

IPD Sharing Access Criteria

Data access requests will be rewiewed by internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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