Clincosm LogoSign in Get a demo

PRURIGAMMA: Frequency and Characteristics of Pruritus in Patients With Monoclonal Gammopathy

Sponsor
University Hospital, Brest (Other)
Overall Status
Completed
CT.gov ID
NCT03832140
Collaborator
(none)
281
Enrollment
1
Location
5.9
Actual Duration (Months)
47.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pruritus is most often secondary to dermatitis but can also occur without skin lesions, it is called pruritus sine materia. The causes of pruritus sine materia are various: haematological (myeloproliferative neoplasia ...), hepatic (cholestasis ...), renal (chronic renal failure, dialysis), endocrine (iron deficiency ...), secondary to drug intake ... or idiopathic when no cause is found.

Gammapathies are among the causes of pruritus sine materia, and as such electrophoresis of serum proteins is usually part of the pruritus assessment to look for monoclonal gammopathy (MGUS, multiple myeloma, Waldenström disease). However, there is very little data on the frequency of pruritus in patients with monoclonal gammopathy and the characteristics of this pruritus. So the aim of this study is to compare the frequency of pruritus between patients with monoclonal gammapathy and controls

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    281 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Frequency and Characteristics of Pruritus in Patients With Monoclonal Gammopathy
    Actual Study Start Date :
    May 24, 2019
    Actual Primary Completion Date :
    Nov 19, 2019
    Actual Study Completion Date :
    Nov 19, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with monoclonal gammopathy
    patients with a normal plasma protein electrophoresis

    Outcome Measures

    Primary Outcome Measures

    1. Frequency of pruritus [through study completion, an average of 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria for case :

    Major patient Realized Serum protein electrophoresis between 2014 and 2017 Hematology follow-up at Brest CHR Positive monoclonal gammopathy Non-opposition formulated

    Inclusion Criteria for Control :

    Major patient Realized Serum protein electrophoresis between 2014 and 2017 Hematology follow-up at Brest CHR Negative gammopathy Non-opposition formulated

    Exclusion Criteria:

    Minor patient Major protected Patient with another haemopathy secreting a monoclonal immunoglobulin (lymphoma, LLC ...) Physical or mental incapacity Refusal to participe

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU de Brest Brest France 29609

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT03832140
    Other Study ID Numbers:
    • PRURIGAMMA (29BRC18.0192)
    First Posted:
    Feb 6, 2019
    Last Update Posted:
    Aug 26, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Paraproteinemias
    Monoclonal Gammopathy of Undetermined Significance
    Pruritus

    Study Results

    No Results Posted as of Aug 26, 2020