RecruitingOBSERVATIONAL

Serial Tumour Biopsies and Blood Biomarkers in Melanoma

Doctors are learning more about advanced melanoma, but sometimes new treatments don't work or stop working over time. This study wants to find out why. We're collecting tiny samples from tumours and blood from patients with advanced melanoma. By examining these samples, we hope to discover 'biomarkers' – tiny signs in the body – that can predict if a treatment is likely to stop working. This could help doctors to adjust treatments sooner and develop new medicines for the future. You can take part if you're 16 or over, have advanced melanoma, and are already receiving treatment as part of your usual NHS care.

At a glance

Status

Recruiting

Sponsor

The Christie NHS Foundation Trust

Enrolment target

300

Start

14 Nov 2018

Estimated completion

01 Jul 2034

Melanoma

What is this study about?

When people have advanced melanoma, doctors often use new treatments that can work very well. However, for some people, these treatments might not work from the start, or they might work for a while but then stop being effective. This study is like a detective investigation, trying to figure out why this happens. We want to understand what changes in the body that can make treatments stop working, and how we can spot these changes early on.

To do this, we'll be collecting samples from patients with advanced melanoma who are already having treatment as part of their regular NHS care. These samples include small bits of tumour tissue, usually taken during surgery, and blood samples. By carefully looking at these samples, we hope to find certain 'biomarkers'. Biomarkers are like natural signals or clues in your body that can tell us about your health and how your illness is responding to treatment. We're especially interested in how these biomarkers change over time.

The main goal of this research is to find new ways to predict when a treatment might stop working. This would allow doctors to know sooner if a treatment needs to be changed. Eventually, this could lead to better and more personalised treatments for everyone with advanced melanoma. We also want to understand what happens to healthy cells around the tumour during treatment, as this could give us more clues about how illnesses and treatments affect the body.

Key takeaways

A research study for patients with advanced melanoma.
Aims to understand why treatments stop working for some people.
Involves collecting tumour and blood samples over time.
No new treatments – you receive your standard NHS care.
Could help develop better treatments and monitoring in the future.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for volunteers who are 16 years old or older and have been diagnosed with advanced melanoma. This means your melanoma is either Stage III (locally advanced) or Stage IV (has spread to other parts of your body).

To join, you need to be receiving treatment for your melanoma as part of your usual care through the NHS. If you agree to provide extra samples for the study, you'll also need to be well enough for us to take small tumour samples and blood tests safely. This usually means your blood clotting ability should be within normal limits.

Unfortunately, you won't be able to join if you can't give your clear permission to take part, or if you have certain infections like HIV or Hepatitis B/C, or a known significant bleeding problem that would make it risky for you to have biopsies or blood tests. We also can't include people for whom taking part might increase health risks for them or the research team.

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 16 years old or over?
Do you have advanced melanoma (Stage III or IV)?
Are you receiving treatment for your melanoma through the NHS?
Are you able to safely have blood tests and small tumour samples taken (if agreeing to provide them)?
Don’t have certain infections like HIV/Hepatitis B/C or severe bleeding problems.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be asked to provide some samples over time. These include small tumour samples and blood samples. Many of the tumour samples will be taken from tissue that is already being removed as part of your normal treatment, for example, during surgery to remove a lymph node or other affected areas. We'll also ask for some extra, very small tumour samples from areas that are easy to reach, specifically for the research. You can still participate even if you don't agree to these extra tumour samples.

You'll also be asked to provide blood samples. These will be taken before any major treatment, and then several times after surgery: at 3 months, and then every 3 months for the first year, as part of your routine follow-up. More blood samples will also be collected if your melanoma comes back or if your treatment changes. Each blood sample will be about 50ml, which is roughly 3-4 tablespoons. We might also ask for other samples like urine, stool, or saliva, if they're available and not needed for your routine care. The study aims to look at these samples for several years, depending on your treatment journey.

Potential risks and benefits

Participating in this study might not directly benefit you, but the information we gather could help improve treatments for future melanoma patients. Taking part involves having extra blood tests and possibly small tumour biopsies. There's a small risk of discomfort, bruising, or a very rare chance of infection or bleeding with these procedures, similar to what you might experience with routine medical tests. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

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

The Christie
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is a 'biomarker'?

Biomarkers are like tiny clues in your body, like certain genes or proteins, that doctors can measure to understand your disease or how well a treatment is working.

Will I get new treatment in this study?

No, this study doesn't involve new treatments. You will receive your usual melanoma treatment as part of your standard NHS care while participating.

Do I have to have extra biopsies?

We will ask if you are willing to have extra, small biopsies for research purposes from easy-to-reach areas, but you can still join the study even if you prefer not to. Many samples will come from tissue already removed during your routine care.

How often will I need blood tests?

You'll have a blood test before treatment, and then several more times during your follow-up care, for example, after surgery at 3 months and then every 3 months for the first year, and if your treatment changes.

Will I find out my personal test results?

The study focuses on research to benefit future patients, not individual results. However, if any findings are important for your immediate health, your medical team will be informed.

How to find out more

Gupta, Dr

avinash.gupta@christie.nhs.uk 0161 446 3472 Official trial record

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