Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04018209
Other study ID # PANAM (29BRC19.0001)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 9, 2019
Est. completion date January 9, 2020

Study information

Verified date July 2019
Source University Hospital, Brest
Contact Jean-Christophe IANOTTO
Phone +33298222523
Email jean-Christophe.ianotto@chu-brest.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 125
Est. completion date January 9, 2020
Est. primary completion date January 9, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France 06 Angers Pays De La Loire
France 03 Annecy Haute-Savoie
France 01 Brest
France 05 Lyon Auvergne Rhônes-alpes
France 11 Morlaix Bretagne
France 10 Quimper Brestagne
France 08 Rochefort Nouvelle Aquitaine
France 04 Roubaix Hauts-de-France
France 09 Saint-Brieuc Bretagne
France 07 Saint-Louis Grand Est
France 02 Villejuif Val-de-marne

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Description of pruritus in patients with myeloproliferative neoplasms Intensity of pruritus (visual analogic scale) at the time of questionnaire completion (Day 0)
Secondary Description of therapies used to treat pruritus Name of drugs used at the time of questionnaire completion (Day 0)