A structured evaluation of a lateral flow test to monitor monoclonal gammopathy compared to standard of care serum testing to improve early diagnosis of myeloma
Monoclonal gammopathies
The MySELF study is an observational, prospective cohort study which identifies patients who will be having blood taken via phlebotomy for sPEP and sFLC testing, as part of their planned clinical care. In parallel, they will undergo the MySELF test and complete a questionnaire on their experiences of the test to provide feedback on the process. For most patients, this will be a one-off test but a cohort of patients, who are already undergoing repeated sPEP and sFLC testing as part of their planned clinical care, will be asked if they are happy to provide repeat MySELF tests at the same time as their routine blood samples (up to a maximum of six timepoints). For the purposes of test development, there should be at least 1 week intervals between sequential tests. However, in the majority of cases, routine monitoring is performed every 3-4 weeks or 2-3 months to coincide with treatment schedules and clinic appointments. This should include: a) Individuals (minimum N=20) who are likely to have stable levels of monoclonal gammopathy over the test time points. These individuals will be identified from outpatient clinic and inpatient lists as patients with known monoclonal gammopathy who are not receiving treatment that is likely to change the monoclonal gammopathy levels. This will identify whether the test is able to accurately track stable disease. b) Individuals (minimum N=20) who have fluctuating levels of monoclonal gammopathy. These individuals will be identified from outpatient clinic and inpatient lists as patients with known monoclonal gammopathy with progressive disease, or are receiving therapy that is likely to change the monoclonal gammopathy levels. This will identify whether the MySELF test is sensitive to change in patient levels over time. These patients will be having routine blood tests (i.e. full blood count, biochemistry and including standard of care monoclonal gammopathy tests) as part of their standard NHS clinical care. We will perform parall
1. Age >18 years 2. Undergoing sPEP and sFLC serum testing as part of routine clinical care 3. Willing to undergo finger prick blood sampling 4. Able to provide informed consent
1. Outside of stated age range 2. Unable or unwilling to provide informed consent