A study looking at the genetics of advanced solid cancers and matching people to early stage targeted treatment trials (TARGET National)
Cancer type:
Status:
Phase:
This study is looking at gene changes in advanced 
. It gives you and your team information on the genetic makeup of your cancer. This might help your team find a suitable early trial of a new targeted treatment for you.
A solid cancer is any type of cancer apart from those of the blood system or lymphatic system such as leukaemia or lymphoma.
More about this trial
Nearly every cell in the body contains . This is your unique genetic code.
In cancer cells the DNA is damaged (faulty). This allows cancer cells to grow out of control.
Doctors can find out the genetic code of cancer by looking at one of the following:
- small pieces of DNA that have leaked from the cancer into the bloodstream. This is called circulating tumour DNA (ctDNA).
- cancer cells in the bloodstream (circulating tumour cells)
- a tissue sample of the cancer from a
biopsy or surgery
Some cancer treatments aim to target particular genetic changes (mutations) in cancer cells. This may help to reduce damage to normal cells and so aims to reduce side effects.
Advanced cancer means a cancer that has spread from where it started to another part of the body. Treatment for advanced cancer depends on various factors including where the cancer is in your body. Treatment can include chemotherapy, surgery, targeted cancer drugs, and radiotherapy. Researchers would like to improve treatment for people with advanced cancer. This includes people who have had all other available treatments.
The main aim of this study is to try and match people with advanced cancer to a clinical trial. This is based on their specific gene changes. These are phase 1 clinical trials.
Other aims of the study include to:
- see how well the targeted treatments work for people taking part in a phase 1 trial
- find new ways of testing for gene changes in cancer cells
- look for
biomarkers to help understand why people respond to treatment differently - learn more about cancer genetics
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 an advanced
solid tumour . Advanced cancer means a cancer that has spread from where it started to another part of the body. - have been referred to an Experimental Medicine Cancer Centre (ECMC) in the UK. Your doctor will know this.
- are suitable for, and well enough to have, an experimental targeted cancer drug in a
phase 1 trial - have a tissue sample available from a
biopsy or surgery if the study team need to access it. This may be because they don't have enough information from your blood sample. Your trial doctor can explain more. - are willing to have blood tests if you take part in a phase 1 trial
- are aged 16 or over
Who can’t take part
You cannot join this study if any of these apply. You:
- have HIV, hepatitis B or hepatitis C
- have COVID-19, or symptoms of COVID-19, at the moment
- have had systematic anti cancer therapy (SACT) within the last 3 weeks. SACT is cancer treatment that reaches the whole body. You might be able to take part if you have had hormone therapy, a
tyrosine kinase inhibitor or antibody therapy in this time and your cancer has got worse. Your doctor will know more. - have a physical or mental health problem that the trial team think will affect you taking part
- have blood
clotting problems that are not controlled with medications - have any other conditions that prevent your study team taking more blood samples or biopsies
Trial design
The researchers are looking for up to 6,000 patients to take part in the UK.
Please note – The researchers might not find gene changes in your cancer. And if they do, it might not mean there is a suitable phase 1 study for you to take part in. All samples help researchers learn more about cancer. They aim to use this information to help improve treatment in the future.
Everyone taking part
Researchers look at everyone’s blood samples in the laboratory. They look for genetic characteristics of the cancer and possible reasons why the cancer has developed. They do this by looking for (ctDNA) or for cancer cells in the bloodstream.
The study team might also look at a tissue sample from your previous biopsy, a new biopsy or surgery. This might be because either:
- not enough circulating tumour DNA can be found in the blood sample or
- no genetic faults are found in the blood sample
Genetic changes
If genetic faults () are found, a team of experts look at the results closely. This is to decide if the mutation is relevant based on the information that we know about cancer already.
The study team will let you know if they find changes that could affect your current cancer care.
The study team also look for a suitable phase 1 clinical trial that you may be able to join. You might need to travel to take part in the phase 1 trial, but the team will take where you live into account.
No genetic changes
Your doctor will talk to you about different treatment options if no relevant genetic changes are found. You won’t be matched with a phase 1 clinical trial.
Samples for research
The study team take blood samples when you join the study. This is to look at your healthy DNA and DNA from your cancer cells. The team try to do blood tests at the same time as any routine blood tests at your clinic appointments.
The team may ask to access a tissue sample from a biopsy you have had before. This is only if they think they need it.
The researchers might ask for a new biopsy sample if there is not one available to use. This is only if it’s safe to do so.
The team ask for your permission to store the blood and tissue for research now and in the future. The researchers aim to:
- learn more about advanced cancer
- find out more about why treatment works for some people but not for others
- improve treatments in the future
The team ask if you would be willing to let them use your blood or tissue samples to grow cancer cells in the laboratory. This is to learn more about your type of cancer. This may involve experiments with animals. This is optional, you can say no to this and still take part in the trial.
You might be asked to give other samples for research. We give more information in the ‘hospital visits’ part of this summary.
Hospital visits
You see the study team and have some tests before you start treatment.
This will include:
- taking your medical history
- blood tests
You might be asked to give another tissue sample (). This is optional. You can say no and still take part in the study.
During treatment
If you do join a phase 1 clinical trial, you may be asked to provide extra blood samples.
This might be a total of 15 extra blood samples throughout this study. Your doctor will try to take these extra samples at the same time as you have blood tests that you need as part of your treatment. This is to look at the ctDNA and other .
The team might also ask you if they can take extra samples when you have any tests that you need during the study. These samples might include:
- a tissue sample (biopsy)
- a sample of fluid drained from your lungs (
pleural effusion ) - a sample of fluid drained from your abdomen (ascitic fluid)
The team ask if you are willing to give a further two biopsy samples if you are having treatment. You have one during treatment and one at the end of treatment. These are optional, you can say no and still take part in the study.
Follow up
The researchers see how you are getting on for up to 2 years. This includes how well any treatment is working if you are taking part in a trial.
The study team look at your medical records every 3 months to find this information out. Or they might phone you.
Side effects
Genetic testing might also show information about:
- your risk of other medical conditions not related to your cancer
- and an increased risk of cancer and other medical conditions for your biological family
You can decide if you do or don’t want to know this information before joining the study. You have genetic counselling before you join the study to help you work through this.
Your trial team go through any possible side effects of treatment with you if you do take part in a phase 1 trial.
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr Matthew Krebs
Supported by
Cancer Research UK
The Christie NHS Foundation Trust
The Christie Charity
The Sir Bobby Robson Foundation
Roche Pharmaceuticals
University of Manchester
Digital Experimental Cancer Medicines Team
Experimental Cancer Medicine Centres (ECMC)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
