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Clinical Characteristics of Aquagenic Pruritus in Patients With Myeloproliferative Neoplasms (PASYMPLE)

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ClinicalTrials.gov Identifier: NCT03688490
Recruitment Status : Completed
First Posted : September 28, 2018
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Tracking Information
First Submitted Date September 20, 2018
First Posted Date September 28, 2018
Last Update Posted Date July 1, 2019
Actual Study Start Date July 17, 2013
Actual Primary Completion Date November 4, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 27, 2019)
Intensity of the pruritus [ Time Frame: 15 days ]
Analogic Visual Scale, from 0 to 10, Worse if >6
Original Primary Outcome Measures
 (submitted: September 26, 2018)
Intensity of the pruritus [ Time Frame: at 15 days ]
Analogic Visual Scale, from 0 to 10, Worse if >6
Change History
Current Secondary Outcome Measures
 (submitted: June 27, 2019)
Duration of the pruritus [ Time Frame: 15 days ]
Timing expresses in minutes
Original Secondary Outcome Measures
 (submitted: September 26, 2018)
Duration of the pruritus [ Time Frame: at 15 days ]
Timing expresses in minutes
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Characteristics of Aquagenic Pruritus in Patients With Myeloproliferative Neoplasms
Official Title Aquagenic Pruritus Among Patients With Myeloproliferative Syndromes (in English) Prurit Aquagénique Dans Les SYndromes MyéloProLifEratifs (in French)
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.

Detailed Description

Patients with myeloproliferative neoplasms identified and followed in our Institution (Brest University Hospital). Patients could be followed for polycythemia vera or essential thrombocythemia or myelofibrosis.

Distribution of the questionnaire to each patients with myeloproliferative neoplasms (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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients followed for myeloproliferative neoplasms in our Institution (Brest University Hospital)
Condition Myeloproliferative Disorder
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Le Gall-Ianotto C, Brenaut E, Gouillou M, Lacut K, Nowak E, Tempescul A, Berthou C, Ugo V, Carré 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 26, 2018)
70
Original Actual Enrollment Same as current
Actual Study Completion Date November 4, 2013
Actual Primary Completion Date November 4, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients followed with myeloproliferative neoplasms
  • suffering from aquagenic pruritus

Exclusion Criteria:

  • Unable to fulfil the questionnaire
  • No written informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03688490
Other Study ID Numbers PASYMPLE
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Brest
Study Sponsor University Hospital, Brest
Collaborators Not Provided
Investigators
Principal Investigator: IANOTTO Jean-Christophe, MD, PhD Hématologie Clinique-Institut de Cancéro-Hématologie
PRS Account University Hospital, Brest
Verification Date August 2018