Clinical Characteristics of Aquagenic Pruritus in Patient... | NCT03688490

Studies
Clinical Characteristics of Aquagenic Pruritus in Patients With Myeloproliferative Neoplasms

NCT03688490

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Jul 1, 2019Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Myeloproliferative Disorder

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 17, 2013Actual

Primary Completion Date

Nov 4, 2013Actual

Completion Date

Nov 4, 2013Actual

First Submitted Date

Sep 20, 2018

First Submission Date that Met QC Criteria

Sep 26, 2018

First Posted Date

Sep 28, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2019

Last Update Posted Date

Jul 1, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intensity of the pruritus	Analogic Visual Scale, from 0 to 10, Worse if >6	15 days

Secondary Outcomes

Measure	Description	Time Frame
Duration of the pruritus	Timing expresses in minutes	15 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients followed with myeloproliferative neoplasms
suffering from aquagenic pruritus

Exclusion Criteria:

Unable to fulfil the questionnaire
No written informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
IANOTTO Jean-Christophe, MD, PhD	Hématologie Clinique-Institut de Cancéro-Hématologie	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27291777	Result	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.

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases