Frequency and Characteristics of Pruritus in Patients With Monoclonal Gammopathy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03832140

Acronym

PRURIGAMMA

Enrollment

281

Registered

2019-02-06

Start date

2019-05-24

Completion date

2019-11-19

Last updated

2020-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Monoclonal Gammopathy, Pruritus

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Frequency of pruritus	through study completion, an average of 1 year

Countries

France

Outcome results