
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
This trial is looking at the amount of tissue a surgeon removes during surgery for melanoma.
It is for people who have melanoma that hasn’t spread. This is stage 2 melanoma.
Doctors diagnose melanoma by removing the abnormal mole or area of skin. They send it to the laboratory to check if it's a melanoma and how thick it is.
You have surgery to remove more tissue if it is a melanoma. This is a wide local excision. The surgeon removes a further area of skin and tissue from around where the melanoma was. This is called a . This helps to reduce the risk of it coming back.
Currently, doctors are uncertain how much skin to remove from around a melanoma. Guidelines in different countries vary in their recommendations on this. For stage 2 melanoma in the UK, the current guidance is a 2 to 3cm margin.
Previous research suggested that a 1cm margin may be enough to reduce the risk of melanoma coming back in the same area. This needs to be tested in a trial of more people before it becomes standard practice.
The main aims of the trial are to find out:
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply.
Who can’t take part
Cancer related
You cannot join this trial if:
Medical and other conditions
You cannot join this trial if any of these apply. You:
You might be able to take part if you are pregnant. This depends on when you can have your surgery. You can talk to the surgical team about this if it applies to you.
This phase 3 trial is taking place worldwide. The team need about 2,998 people to take part. This includes 750 from the UK.
It is a randomised trial. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in.
There are 2 surgery groups. You have one of the following:
There are equal numbers of people in the two groups
At the same time as the wide local excision, everyone will have an operation to remove some lymph glands closest to the melanoma. This is a sentinel node biopsy. It is part of your routine treatment.
Questionnaires
The trial team ask you to fill out a few questionnaires:
Some of the questionnaires ask about side effects, pain and how you are feeling. This is a quality of life study.
Some questionnaires ask about:
They also ask about any help you need day to day, time off work or usual activities, and any effect on your income.
You see the doctor before you can take part. During an initial visit the doctor will check if you are suitable for the study. You also have a .
The doctor will ask you questions about any surgical complications or new diagnoses since your last visit. They will also check your and for any changes in your medications.
You have a blood test if this is routine at your hospital.
Before your surgery you:
After surgery you see the doctor for a check up at:
This follow up schedule is similar to one you would have had if you didn’t take part in this trial. Any other clinical visits your doctor feels are necessary, will take place as normal.
The trial team monitor you during the trial. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
The most common side effects of having a wide local excision include:
Your doctor will talk to you about all the possible side effects before you join the trial.
We have more information about surgery for melanoma.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Marc Moncrieff
National Institute for Health Research (NIHR)
Norfolk & Norwich University Hospitals NHS Trust
Melanoma and Skin Cancer Trials (MASC Trials)
Surgical Trials Intervention Unit (SITU)
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.