RecruitingOBSERVATIONAL

A Prospective Long-term Observational Study in Patients With Monoclonal Gammopathy of Undetermined Significance

The SECURE study is investigating Monoclonal Gammopathy of Undetermined Significance (MGUS), a condition that can sometimes, but rarely, develop into a blood cancer called Multiple Myeloma (MM). In the UK, over 5000 people each year are diagnosed with MM. This study aims to understand MGUS better, including how many people with MGUS go on to develop myeloma, and how we currently screen for and monitor it. By improving our understanding of MGUS, the study hopes to find ways to diagnose myeloma earlier, as early diagnosis can significantly improve treatment outcomes. It will also look at how MGUS affects people's quality of life and if family history plays a role. The study is funded by Cancer Research UK and the National Institute for Health Research.

At a glance

Status

Recruiting

Sponsor

Oxford University Hospitals NHS Trust

Enrolment target

2,000

Start

06 Sep 2023

Estimated completion

01 Dec 2032

MGUS

What is this study about?

Myeloma is a rare type of blood cancer that affects thousands of people in the UK each year. Interestingly, all cases of myeloma start from a condition called Monoclonal Gammopathy of Undetermined Significance (MGUS). MGUS is quite common, affecting about 3.2% of people aged 50 and over. However, most people with MGUS will never develop myeloma – only about 1% each year will see their condition progress.

While most people with MGUS don't have any symptoms, a small number experience complications. This group is then referred to as having Monoclonal Gammopathy of Clinical Significance (MGCS). Currently, myeloma is often diagnosed quite late, later than most other cancers. This is partly because MGUS is usually found by accident during blood tests for other reasons, and there isn't a clear, consistent way to monitor people once MGUS is found.

The SECURE study wants to change this. It aims to gather important information about MGUS to help doctors understand it better. This includes finding out exactly how often MGUS turns into myeloma, and how we currently check for, diagnose, and monitor people with MGUS and MGCS in the UK. The study will also look at whether family history or other personal factors play a role in developing MGUS, and how living with MGUS impacts people's well-being and daily life. Ultimately, by learning more about MGUS, the study hopes to pave the way for earlier and more effective diagnosis of myeloma.

Key takeaways

The study aims to understand MGUS better to help diagnose myeloma earlier.
Participation involves filling out annual surveys and possibly providing blood samples.
It's an observational study, meaning no new treatments are given.
Your involvement could help many future patients.
You can stop participating at any time.
The study is backed by Cancer Research UK and the National Institute for Health Research.

Who may be eligible?

The SECURE study is looking for adults aged 18 and over who have been told by their medical team that they have a confirmed or suspected case of MGUS. This means your doctor has identified that you have MGUS and thinks you might be a suitable participant.

However, there are certain situations where you wouldn't be able to join. For example, if you are under 18 years old or if you are unable to understand and agree to take part in the study. Also, if there's no clear evidence you have MGUS, or if your condition is changing quite rapidly at the time of diagnosis or when you might join the study, you wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been told by your doctor you have confirmed or suspected MGUS?
Are you able to understand and agree to take part in the study?
Is your MGUS condition not changing rapidly right now?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the SECURE study, your clinical care team will formally invite you. Once you agree, you will be asked to fill out surveys and answer questionnaires once a year. This will continue for a period of up to 5 years, or until your medical condition changes in a way that means you are no longer suitable for the study. Some participants, chosen from the 20 NHS sites across the UK involved in the study, may also be asked to provide blood samples as part of their participation.

Potential risks and benefits

Taking part in the SECURE study won't directly treat your MGUS, but your contribution could greatly benefit future patients. By sharing your experience, you'll help researchers understand MGUS better and potentially lead to earlier diagnosis of myeloma for others. The main commitment is giving your time to complete surveys and possibly provide blood samples, which carry minimal risk. You have the right to change your mind and stop participating at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Secure Study
Verified postcode
Oxford, United Kingdom· Recruiting

Common questions

What is MGUS?

MGUS stands for Monoclonal Gammopathy of Undetermined Significance. It's a condition where your body makes an unusual protein, but it usually doesn't cause problems and rarely turns into cancer.

What is myeloma?

Myeloma is a type of blood cancer that affects certain cells in your bone marrow. It's serious but can often be managed, especially if caught early.

Will I get treatment if I join the study?

No, this study is about observation and understanding MGUS better. It will not provide new treatments for your condition.

How long will I be in the study?

You'll be asked to participate for up to 5 years, or until your condition changes.

Who is funding this research?

This study is funded by two well-known UK organisations: Cancer Research UK and the National Institute for Health Research.

How to find out more

Richard Brouwer, BSc

richard.brouwer@ouh.nhs.uk 07594301699 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.