MySELF study
Research type
Research Study
Full title
Monoclonal Gammopathy and Structured Evaluation of Lateral Flow test
IRAS ID
352718
Contact name
Tracey Chan
Contact email
Sponsor organisation
Director, Research Strategy and Services Division
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Monoclonal gammopathy of undetermined significance (MGUS) is an early indicator of the blood cancer multiple myeloma (MM). MGUS is common; 750,000-1,100,000 people have MGUS in the UK and many of these individuals are undiagnosed. We can detect MGUS as abnormal (monoclonal) proteins in the blood using serum protein electrophoresis (sPEP) and serum free light chain (sFLC) tests. These tests require patients to visit GPs or hospitals for a blood sample, which is then sent to a clinical laboratory for testing.
Monitoring MGUS patients helps to identify when they progress to MM. With this knowledge, we can start treatment earlier and reduce the chances of MM causing organ damage such as kidney failure and bone fractures. Currently MGUS monitoring in the UK occurs in hospital clinics, general practice and laboratory based services. It places a high burden on the NHS.
Our surveys have identified that many patients would be keen to try an “at-home” monitoring technique, as regular appointments for blood tests can be time-consuming and expensive. We have developed a lateral flow test (MySELF test) that monitors MGUS using a finger-prick blood sample. Results can be immediately available and linked into a digital monitoring service that will reduce the time it takes for results to go back to patients. We anticipate that these changes will also make it cheaper for the NHS and patients.
In our research study, we will identify up to 500 patients from University Hospitals Birmingham NHS Trust haematology department who are having standard blood tests for MGUS as part of their routine NHS treatment. We will ask them if they are willing to also have the MySELF test and then compare the two results to see if the MySELF test is as accurate.REC name
West Midlands - Black Country Research Ethics Committee
REC reference
25/WM/0134
Date of REC Opinion
14 Aug 2025
REC opinion
Further Information Favourable Opinion