Unravel MGUS (Monoclonal Gammopathy of Unknown Significance)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

664 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2021-02-28

Brief Summary

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This is a study to investigate the functional consequences of paraprotein production in MGUS (Monoclonal Gammopathy of Unknown Significance).

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Detailed Description

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Monoclonal gammopathy of unknown significance (MGUS) is a common haematological condition. It is characterised by proliferation of a B lymphocyte clone and it's associated antibody (paraprotein). In most cases there are no clinical symptoms, however, in a small number of individuals there may be an interaction of the paraprotein with a molecule expressed by the body (self antigen). This can have effects on the normal function of this molecule and/or cause disease.

The study aims to investigate the functional consequences of paraprotein production in MGUS.

Conditions

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Monoclonal Gammopathy of Unknown Significance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All participants

Nurse visit for blood sample, questionnaire and phone call

Blood sample taken

Intervention Type OTHER

Answering a lifestyle questionnaire

Intervention Type OTHER

Follow-up phone call from researcher (two years after first visit)

Intervention Type OTHER

To enquire about status of participants monoclonal gammopathy of unknown significance, and whether there has been progression to multiple myeloma.

Interventions

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Blood sample taken

Intervention Type OTHER

Answering a lifestyle questionnaire

Intervention Type OTHER

Follow-up phone call from researcher (two years after first visit)

To enquire about status of participants monoclonal gammopathy of unknown significance, and whether there has been progression to multiple myeloma.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Participants must comply with the following criteria in order to be eligible for the study:

* Be aged ≥18 years at the time the informed consent form is signed
* Have a confirmed and documented Monoclonal Gammopathy of Unknown Significance (MGUS) diagnosis
* Read and understood the participant information sheet, and signed an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved informed consent form prior to any study- specific evaluation

Exclusion Criteria

Participants will be excluded from joining the study if they match any of the criteria below:

* Pre-existing diagnosis of myeloma/lymphoma
* Participation in a therapeutic clinical study within 28 days or (5 half lives, whichever is longer) of enrolment or during this study
* Any other reason the Clinical Investigator (CI) considers the participant should not join the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No