SECURE
Research type
Research Study
Full title
A prospective long-term observational study in patients with monoclonal gammopathy of undetermined significance
IRAS ID
304209
Contact name
Karthik Ramasamy
Contact email
Sponsor organisation
Oxford University Hospitals NHS Foundation Trust
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
Monoclonal gammopathy of undetermined significance (MGUS) is the distinct precursor to Multiple Myeloma (MM), a rare blood cancer affecting over 5000 people a year in the UK. Although Myeloma is the only clinical state offered therapy, a small number of MGUS patients suffer complications and these are referred to having monoclonal gammopathy of clinical significance (MGCS). Early detection is a high priority for Myeloma patients and drastically improves survival but has the longest diagnostic delay of any cancer. Most avoidable delays occur in primary care for reasons including inconsistent MGUS testing and follow-up. Because MGUS precedes all myelomas, an early diagnosis strategy is to regularly monitor people with MGUS for progression to myeloma. Progression risk, although difficult to define is ~1%/year with a general MGUS population prevalence of 3.2% in individuals >50 years. Unfortunately, MGUS is often diagnosed incidentally and 80–90% of myelomas are diagnosed without first receiving an MGUS diagnosis.
SECURE is a prospective long-term observational study, which will help confirm the rate at which patients with MGUS progress to a diagnosis of MM. We hope to further our understanding of screening, diagnosis, and monitoring patterns of patients with MGUS and MGCS in the UK. We also aim to improve the understanding of demographic associations and family linkage of those with MGUS. Currently there is limited information available to understand the psychological needs after diagnosis and during the progression of the disease, so the study will additionally focus on this along with the quality of life of participants.
Participants will be required to answer surveys and questionnaires annually for a period of 5 years or until disease progression across 20 NHS sites and will be asked to provide blood samples for biomarker and metabolomic analysis. Funding is initially provided by CRUK Cancer Centre Oxford and the Medical Research Council.REC name
Wales REC 3
REC reference
22/WA/0291
Date of REC Opinion
19 Oct 2022
REC opinion
Favourable Opinion