A study looking at a blood test to see whether further treatment is needed after having surgery to remove melanoma skin cancer (DETECTION-2)

Cancer type:

Melanoma

Skin cancer

Status:

Open

Phase:

Other

This is a feasibility study Open a glossary item looking at using a blood test called circulating tumour DNA to see if further treatment is needed after melanoma surgery.

Cancer Research UK supports this study.

More about this trial

After having surgery to remove the melanoma your doctor might suggest you have some further treatment. This is called adjuvant treatment. Doctors use adjuvant treatment to prevent the melanoma coming back.

But the melanoma may not come back after surgery even if you do not have adjuvant treatment. So some people will have unnecessary treatment. As with all treatment, adjuvant treatment has side effects.

At the moment, there is no way of telling who might need adjuvant treatment or when is the best time to start adjuvant treatment if needed.

Small pieces of the DNA Open a glossary item in the melanoma cells can break off and go into the blood. These are called circulating tumour DNA (ctDNA) . There is a test that can look for these small pieces of DNA in the blood. This is called the ctDNA blood test.

Researchers think they might be able to use the ctDNA blood test to find out if and when people might need adjuvant treatment.

In this study, half the people will have adjuvant treatment after their surgery. The other half won’t have adjuvant treatment but will have regular ctDNA testing. If the test shows that there is tumour DNA in the blood, then they will have adjuvant treatment.

The aim of this feasibility study is to see if it would be possible to do this type of research with a large number of people in the future.

Who can enter

The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study 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 study if all of the following apply. You:

have melanoma skin cancer (cutaneous melanoma)
have stage 2B, stage 2C or stage 3A melanoma
have had surgery to completely remove the melanoma within the 12 weeks before being put into a group (randomisation )
have an examination by your doctor that shows there is no sign of melanoma within the 4 weeks before randomisation and a scan within 12 weeks
have a gene change (mutation ) that the team can use for the ctDNA. They will test a piece of melanoma tissue from your surgery for this.
are fully active but might not be able to do heavy physical work (performance status 0 or 1)
have satisfactory blood test results
are willing to use reliable contraception if there is any chance you or your partner could become pregnant
are at least 16 years old

Who can’t take part

You cannot join this study if any of these apply. You:

have already had treatment with an immunotherapy , chemotherapy , vaccine or targeted drug
have had another cancer within the past 3 years. This is apart from successfully treated non melanoma skin cancer , melanoma carcinoma in situ (stage 0) or any other cancer that was successfully treated and there has been no sign of it for at least 3 years.
have an autoimmune disease apart from certain ones. This only applies to certain people and your doctor will know if it applies to you.
are taking medication that affects how well your immune system works. This only applies to certain people and your doctor will know if it applies to you.
have scarring or inflammation of the lung tissue
have HIV, hepatitis B or hepatitis C
are allergic or sensitive to the treatments used
are pregnant or breastfeeding

Trial design

When you agree to take part in the study, the team will ask for a sample of the melanoma tissue that the surgeon removed during surgery. They will use this to look for certain gene changes (mutations Open a glossary item ) in the cancer cells. You can continue in the study if the cancer cells have a gene change.

If the cancer cells do not have a gene change, you cannot continue in the study. In this case your doctor will discuss with you what treatment options there are.

This is a feasibility study. The team need at least 50 people to join. It is a randomised study. A computer puts you into 1 of 2 groups. Neither you nor your doctor chooses which group you go into. The 2 groups are:

standard adjuvant treatment
ctDNA testing

19977-randomisation.png

Standard adjuvant treatment
After surgery, you have the standard adjuvant treatment. This might be a targeted or immunotherapy drug. Your doctor will tell you which treatment you are to have. You have treatment for a year.

If the melanoma comes back your doctor will discuss with you what the treatment options are.

ctDNA testing
After surgery you have regular ctDNA testing.

If there is no ctDNA, this is a negative ctDNA result. In this case you continue in the study.

If there is ctDNA in the blood at any time during the study it is a positive ctDNA result. In this case, you go back to the clinic to see the doctor. They will discuss the test result with you, what the next steps are and what standard treatments are available. You stay in the study but do not continue to have the ctDNA testing.

Sometimes, a result cannot be given and this is an uninformative ctDNA result. In this case the team will contact you to arrange to have another test at your convenience. This does not mean you are more likely to have ctDNA in the blood.

If the melanoma comes back
Melanoma might come back near where the original one was even though you have a negative ctDNA result. In this case you will have surgery to remove it. You might have other standard treatment afterwards and continue having the ctDNA test. Your doctor will discuss all of this with you if it happens.

If the melanoma comes back in another part of the body, you will have standard treatment. Your doctor will discuss this with you if it happens.

Hospital visits

Everyone sees the doctor for a physical examination Open a glossary item and tests before joining the study. The tests are:

blood tests, this does not include the ctDNA blood test
a CT scan, an MRI scan or a PET scan, your doctor will tell you which scan you are to have

Standard care group
Your doctor will tell you about the treatment you are having. They will see you regularly during treatment. This is to see how you are and for tests.

ctDNA test group
You see the doctor and have a ctDNA test when you join the study and then:

every 3 months for years 1 to 3
every 6 months for years 4 and 5

You will have another ctDNA test done if the melanoma comes back.

Scans
Everyone has a scan:

every 3 months for year 1 and then
every 6 months for years 2 and 3 then
once a year for years 4 and 5

You will also have scans done if the melanoma comes back.

After 5 years
You are in the study for 5 years. After this, the study team might contact you for up to 15 years to see how you are.

Side effects

The study team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.

Giving a blood sample is generally a very safe procedure. After the blood sample you might:

feel some pain where they took the sample
have some bleeding or bruising
feel a bit lightheaded

After surgery, the adjuvant treatment you have might be an immunotherapy drug or a targeted cancer drug. Your doctor will tell you which treatment you are to have and will tell you about the side effects. They will also answer any questions you have.

Immunotherapy drugs can affect the immune system Open a glossary item . This may cause inflammation and other reactions in different parts of the body. For many people the inflammation and reactions are not too bad. For some people they can cause serious side effects.

These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for.

If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy.

We have information about targeted drugs and immunotherapy for melanoma.