A feasibility trial to assess recruitment rates and ctDNA reporting times for patients with resected stage IIB/IIC/IIIA melanoma
Melanoma is a serious type of skin cancer. Surgery cures most early-stage cases, but the cancer can sometimes return. Currently, patients who have had surgery choose between regular hospital scans or taking preventive cancer drugs for a year. These drugs can work well, but they also cause unpleasant side effects. This trial, called DETECTION-2, tests a new approach using a blood test that looks for tiny pieces of cancer DNA, known as ctDNA. This blood test can often spot signs of cancer returning before they show up on routine scans. Participants are randomly placed into one of two groups: one receives standard preventive drug treatment, while the other is monitored with regular blood tests and only given drugs if cancer DNA appears. This study checks whether this testing approach is fast and practical across NHS hospitals before launching a larger trial.
At a glance
What is this study about?
Melanoma is an aggressive form of skin cancer. For most people with early-stage disease, an operation to cut out the tumour cures the condition. Even so, there is a small risk that microscopic cancer cells remain behind and spread to other parts of the body. To prevent this, patients are currently offered either close monitoring with regular scans or a full year of drug treatment. Taking preventive medication can help, but it also means many people endure difficult side effects from drugs they might never have needed.
Researchers are investigating a smarter, more targeted way to monitor patients using a blood test called a ctDNA test. When cancer cells grow, they shed tiny fragments of their genetic code (DNA) into the bloodstream. A sensitive blood test can find these fragments months before a tumour would show up on a standard CT or MRI scan. By using this test, doctors hope they can safely hold off on drug treatment and only start it if the blood test shows that cancer cells are active.
This trial is a 'feasibility study'. This means the researchers want to see whether running a trial like this is practical in real-world NHS clinics before launching a much larger national study. They need to find out how many patients are willing to take part and whether hospital laboratories can return the blood test results quickly enough to guide patient care safely.
Key takeaways
- The trial tests whether a blood test can safely tell who needs drug treatment after melanoma surgery.
- It aims to spare patients from unnecessary drug side effects while still catching any return of cancer early.
- Participants are randomly assigned to either standard preventive drugs or regular blood test monitoring.
- All patients will still receive standard hospital scans and regular check-ups for at least five years.
- Taking part is completely voluntary and you can withdraw at any time without affecting your NHS care.
Who may be eligible?
This study is open to people aged 16 and over who have been diagnosed with stage IIB, IIC, or IIIA melanoma of the skin. To take part, you must have had your melanoma completely removed by surgery within the past 12 weeks, and your recent scans must show no remaining signs of cancer.
Your tumour must also carry a specific genetic change (such as a mutation in the BRAF, NRAS, or TERT genes). Doctors will test the tissue already removed during your surgery to see if it has one of these changes, which gives the blood test a clear target to look for. You will also need to be in generally good health, with normal blood counts and liver and kidney function.
You cannot join if you have already had drug treatments for this melanoma, such as chemotherapy or immunotherapy. You will also not be able to participate if you are pregnant, breastfeeding, or have had another form of cancer within the past three years (apart from successfully treated minor skin cancers).
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.
- I am 16 years of age or older.
- I have been diagnosed with stage IIB, IIC, or IIIA skin melanoma.
- My melanoma was completely removed by surgery within the last 12 weeks.
- My most recent scans show no current signs of cancer.
- I have not previously received drug treatments (such as immunotherapy) for this melanoma.
- I am not currently pregnant or breastfeeding.
What does participation involve?
If you decide to join, you will be randomly placed by a computer into one of two groups. If you are in the standard care group, you will receive preventive drug treatment for up to one year, with hospital visits based on your specific medicine. If you are in the blood test monitoring group, you will not receive drugs right away; instead, you will have regular clinic visits and blood tests every three months for the first three years, and then every six months during years four and five. Everyone in both groups will continue to have standard NHS imaging scans (such as CT, MRI, or PET scans) on a regular schedule. If your blood test shows cancer DNA or if your scans show the cancer has returned, your doctor will discuss starting cancer treatment right away. Overall, you will be followed up in the study for at least five years.
Potential risks and benefits
Locations (13)
- The ChristieApproximateManchester, England
- AddenbrookesApproximateCambridge, England
- Poole General HospitalApproximatePoole, England
- Royal Preston HospitalApproximatePreston, England
- Southampton General HospitalApproximateSouthampton, England
- Weston Park Cancer CentreUnverifiedSheffield, England
- Beatson West of Scotland Cancer CentreUnverifiedGlasgow, Scotland
- Royal United Hospital BathUnverifiedBath, England
- Churchill HospitalUnverifiedOxford, England
- Royal Marsden HospitalUnverifiedSutton, England
- The Royal Marsden HospitalUnverifiedLondon, England
- St James University HospitalUnverifiedLeeds, England
Common questions
What is ctDNA?
ctDNA stands for 'circulating tumour DNA'. These are tiny pieces of genetic material that cancer cells shed into your bloodstream as they break down. Doctors can detect these fragments with a simple blood test.
Can I choose which group I am in?
No. To ensure the results are fair and scientifically accurate, a computer randomly assigns you to either the standard drug treatment group or the blood test monitoring group.
What happens if my blood test comes back positive?
A positive test means tiny traces of cancer DNA were detected. If this happens, your doctor will review your results promptly and offer you standard NHS cancer treatments.
Will I still get normal hospital scans?
Yes. Regardless of which group you are placed in, you will still receive all routine hospital imaging scans (such as CT or MRI scans) to keep a close eye on your health.
Will taking part cost me anything?
No. The trial tests, extra blood checks, and study treatments are provided through the NHS and funded by Cancer Research UK. You may also be able to claim back certain travel expenses.
How to find out more
Paul Lorigan
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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