Unravel MGUS (Monoclonal Gammopathy of Unknown Significance)
September 1, 2020 updated by: RxCelerate Ltd
Understanding Monoclonal Gammopathy of Unknown Significance (MGUS): A Research Study to Investigate the Functional Consequences of Paraprotein Production in MGUS
This is a study to investigate the functional consequences of paraprotein production in MGUS (Monoclonal Gammopathy of Unknown Significance).
Study Overview
Status
Unknown
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
664
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, SE1 9RT
- Guy's and St. Thomas' Hospital
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Newcastle upon Tyne, United Kingdom, NE7 7DN
- Freeman Hospital
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Nottingham, United Kingdom
- Nottingham City Hospital
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Rotherham, United Kingdom, S602UD
- Rotherham Hospital
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Berkshire
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Reading, Berkshire, United Kingdom
- Royal Berkshire Hospital
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Cambridgeshire
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Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
- Addenbrookes Hospital
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Devon
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Torquay, Devon, United Kingdom
- Torbay Hospital
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West Midlands
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Birmingham, West Midlands, United Kingdom
- Heartlands Hospital
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West Yorkshire
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Leeds, West Yorkshire, United Kingdom
- St James's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study will recruit patients diagnosed with Monoclonal Gammopathy of Unknown Significance.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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All participants
Nurse visit for blood sample, questionnaire and phone call
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To enquire about status of participants monoclonal gammopathy of unknown significance, and whether there has been progression to multiple myeloma.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Clinical assays (i.e. Haematology, biochemistry, immunology, endocrinology): to capture the number of assay phenotypes that are statistically different from normal ranges.
Time Frame: Up to 4 years from study start
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For clinical assays with defined normal ranges, we will capture those results that are significantly outside of normal range.
For those with no generally accepted normal ranges, the results will be compared against results from the other individuals.
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Up to 4 years from study start
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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The number of conversions to multiple myeloma
Time Frame: 2 years after the first visit
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2 years after the first visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jill Reckless, RxCelerate Limited
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2016
Primary Completion (Actual)
February 28, 2019
Study Completion (Anticipated)
February 28, 2021
Study Registration Dates
First Submitted
September 15, 2016
First Submitted That Met QC Criteria
October 13, 2016
First Posted (Estimate)
October 14, 2016
Study Record Updates
Last Update Posted (Actual)
September 2, 2020
Last Update Submitted That Met QC Criteria
September 1, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HAF 01
- 193751 (Other Identifier: IRAS (Integrated Research Application System))
- 16/EE/0071 (Other Identifier: East of England - Cambridge South Research Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.