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NCT03832140 Clinical Trial

Frequency and Characteristics of Pruritus in Patients With Monoclonal Gammopathy

Pruritus Clinical Trial

— PRURIGAMMA  

Official title:
Frequency and Characteristics of Pruritus in Patients With Monoclonal Gammopathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03832140
Other study ID # PRURIGAMMA (29BRC18.0192)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 24, 2019
Est. completion date November 19, 2019

Study information
Verified date August 2020
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 281
Est. completion date November 19, 2019
Est. primary completion date November 19, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHRU de Brest Brest

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of pruritus through study completion, an average of 1 year
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