A trial to develop a blood test to detect lung cancer and predict how well its treatment will work (LERG-NSCLC1)

This trial will look at cell changes in people having surgery or chemotherapy treatment for non small cell lung cancer.

Every cell in our bodies contains a substance called DNA. DNA controls how our cells behave, and in turn how our body works. It is what our genes and chromosomes are made of. Your genes may affect your chance of having a certain disease, or how you respond to a particular drug.

DNA changes when certain chemicals attach to it. This is called ‘DNA methylation’. Different cancers and treatments show different patterns of methylation. These differences show up in blood and tissue samples. The patterns sometimes change during a course of treatment. Researchers want to test blood and tissue from people with lung cancer to study these patterns. They will gather treatment results, and build a record (‘epigenetic profile’). If they get enough samples, they may see links between certain DNA methylation patterns and treatment outcomes.

The aim of this trial is to study epigenetic profiles to develop a blood test to detect lung cancer. And show how treatment is working. In future, this could help doctors predict how well lung cancer treatment will work for each person. You will not have any direct benefit from taking part in this trial, and it is unlikely to change your treatment plan in any way. But the results of the trial will be used to help people with cancer in the future.

Recruitment

Start 03/08/2007

End 28/02/2013

Phase

Phase 1

You can enter this trial if you

Have never had cancer and are in good health
Have been diagnosed with non small cell lung cancer but have not had any treatment yet and are due to have either surgery for lung cancer or chemotherapy for lung cancer

You cannot enter this trial if you

Have already started treatment for non small cell lung cancer
Have had any other cancer except carcinoma in situ of the cervix or basal cell carcinoma that have been removed with surgery (resected)

This trial will not affect your care or treatment and is looking to translate a scientific discovery into a new test. Researchers call this a non interventional translational trial. If you would like to take part, please ask your cancer doctor to email the chief investigator Dr Peter Schmid (p.schmid@imperial.ac.uk). The trial team will send your doctor the information and equipment they will need for you to take part.

This trial will recruit 1,000 people into 3 groups. You will be in group 1 if you are waiting for surgery. You will be in group 2 if you are due to start chemotherapy. Group 3 is for healthy volunteers (control group) and has already recruited enough people.

Everyone in the trial will have some blood tests. If you are in group 1 or 2, researchers will also study a sample of your cancer (biopsy). If you are having surgery, they will use a sample taken during your operation. If you are having chemotherapy, they will look at the biopsy from your lung cancer tests.

The trial is split into 2 stages. Stage 1 uses the first 500 people recruited into groups 1 and 2, and the first 100 healthy volunteers from group 3. This stage will identify DNA methylation patterns linked to lung cancer. Researchers will then develop a set of characteristics (‘model’) to predict lung cancer from a blood test.

Stage 2 of this trial will use the final 200 people from groups 1 and 2, and the last 200 healthy volunteers from group 3. Researchers will use blood and tissue samples from these people to test the model developed in stage 1.

The stage you take part in will depend on when you enter the trial. You will have the same tests as the rest of your group, even if they are in the other stage.

If you are in group 1, you will have a blood test

One week before your surgery for lung cancer
The day after your surgery
One week after your surgery

When you have finished the trial, you will continue to see your trial doctor and have a blood test

Every 3 months for the first 3 years
Every 6 months for years 4 and 5
Once a year after this

If you are in group 2, you will have a trial blood test

Two weeks before you start chemotherapy for lung cancer
On days 1 and 8 of your first cycle of chemotherapy
On the first day of all other chemotherapy cycles

When you have finished the trial, you will continue to see your trial doctor and have a blood test every 2 or 3 months.

As there is no treatment as part of this trial, there are no side effects. You may have a small bruise where you had your blood test.

You can find out more about surgery for lung cancer and side effects of chemotherapy for lung cancer on CancerHelp UK.

Location of trial

For more information

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