A study looking at changes to the liver and the immune system to improve the diagnosis of cancer (DELPHI)
Cancer type:
Status:
Phase:
This study is looking at changes to the liver and the 
which could help diagnose liver cancer at an early stage.
It is for people who have either:
- cancer of the liver, bile duct and gallbladder or
- a long term condition affecting either the liver, bile duct or gallbladder which is not cancer but increases the risk of cancer in the future
The study is part of a larger research programme called DeLIVER that is looking at improving the diagnosis of liver cancer.
More about this trial
We know from research that people with certain long term conditions affecting the liver, bile duct or gallbladder are at increased risk of developing cancer.
People with these long term conditions may have regular of the liver and blood tests. This aims to try to pick up cancer in its early .
Sometimes the tests don’t detect cancer at an early stage. This means cancer is being diagnosed later when it causes symptoms. More is more difficult to treat.
Researchers would like to improve the diagnosis of cancer in people at higher risk of developing it. They are doing this study to try and find new ways to do this.
We know from research that play a part in killing cancer cells before they have chance to grow. Because of this, doctors want to look more closely at the immune system. In this study, the researchers would like to look:
- for ways to spot very early cancer that can’t be seen on a scan, using
markers the immune system made in response to the cancer, or proteins that have been made by the cancer - at if they can see who is at high risk of developing cancer due to immune cells not looking for early cancer cells properly
The researchers will use samples of blood, urine, and tissue from the liver to look at:
DNA released by liver cellsbiomarkers which may be used to spot cancer early- the different types of immune cells in the liver and what they are doing
- differences in the samples between people with cancer and those with a liver condition
The main aim of the study is to find changes in the liver, blood, urine or bile of people who have liver conditions that could tell us their risk of cancer in the future.
Please note - you won’t directly benefit from taking part in this trial. Taking part will not change your treatment.
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 trial if all of the following apply. You:
- have cancer, or your doctor thinks you might have cancer, of either the liver, bile duct or gallbladder. This includes if you have cancer that has spread from another part of the body. Or you have certain long term conditions affecting either the liver, bile duct or gallbladder that is not cancer. Your doctor can explain more.
- are aged 18 to 75
Who can’t take part
You cannot join this study if any of these apply. You:
- are pregnant
- have any medical conditions or social problems that the trial team think would make it unsafe for you to take part. Your doctor can explain more.
Fine needle aspiration
There is an optional part of the study. If you choose to take part, you have a (FNA). There are other entry conditions for this part of the study. As well as the above, you may be able to join this part of the study if all of the following apply. You:
- have had a scan of your upper tummy (abdomen) in the last year
- have had satisfactory blood test results in the 30 days before your FNA
You cannot join the FNA part of the study if any of these apply. You:
- have another medical condition which means you are more likely to have side effects from an FNA. Your doctor will know more.
- are taking any blood thinning medication, or medication to prevent blood clots
- have
ascites
Trial design
This study is taking place in the UK. The team need up to 100 people to take part. This will be:
- up to 30 people with cancer
- up to 70 people with long term conditions
The study lasts for around 20 years.
Active phase
The active phase is the first part of the study. It lasts around 5 years.
Screening
You see the study doctor before you take part. This is called the screening visit. You can ask any questions you have about the study. You also:
- tell the team about your medical history
- sign the
consent form
You might have blood tests to see if it’s safe for you to have a fine needle aspiration (FNA). Not everyone taking part has an FNA.
Baseline
You have a second hospital visit called the baseline visit. This might be on the same day as your screening visit. Or it can be up to 30 days later. The study team will work around what’s best for you.
At this visit you have blood tests and you give a urine sample. You also have your FNA at this visit if you’re having one.
Fine needle aspiration (FNA) and liver biopsy
You might have a fine needle aspiration (FNA) as part of this study. This is optional. You can say no and still take part in the main study.
The researchers use a thin needle to take a small sample of cells from your liver. You have this as an outpatient and with . The procedure itself takes around 20 minutes.
You have up to 4 other FNA procedures as part of the study. This is only if your condition changes. You have the FNA alongside your blood and urine tests.
You might have a liver biopsy as part of the study. This is only if you’re having liver ablation as part of your routine treatment. The biopsy is optional. You can say no and still take part in the main study.
The team compare samples from patients with cancer to those of patients with other diseases of the liver who are at risk of developing cancer in the future. They look for differences and what might be making the cancer grow.
If you have an FNA you have a questionnaire to take home and post back. You fill it in to let the study team know how you got on after the test. The team will call you to see how you are if you don’t send the questionnaire back.
Follow up visits
You see the study team up to 4 other times if your condition changes. This could be because:
- there is now no sign of your cancer on tests and scans or
- your cancer has come back having gone away or
- you have been diagnosed with cancer
You have more blood tests and give another urine sample if anything changes.
Passive phase
The passive phase is the second part of the study. It lasts 15 years. The study team access your medical records to get information about your condition or cancer. They might use your NHS Digital records too.
They look at any test or scan results and at your general health.
The study team organise this. You don’t have to do anything.
Samples for research
The study team will ask to look at any samples, or collect new samples, from when you have a test or procedure as part of your routine care. This includes if you have:
- a liver biopsy
- an endoscopic retrograde cholangio pancreatography (ERCP) – the team collect a sample of bile
- surgery
You don’t have any extra tests or procedures for these research samples.
Hospital visits
You come back to the hospital only if your condition changes. This can be from 30 days after you join to the end of the active phase.
At each visit you have blood tests, and you give a urine sample.
You have an FNA if this is something you have agreed to.
The follow up visits can take up to 2 hours depending on if you have an FNA.
Side effects
You might have some slight bleeding or bruising from the blood samples.
You might have some mild discomfort after your fine needle aspiration. During and after a fine needle aspiration there is a very small risk of:
- bleeding
- a hole in the lung, this is called a lung perforation
- injuring a bile duct in the liver
We have more information about having a fine needle aspiration on our biopsy page.
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 Rory Peters
Supported by
Cancer Research UK
University of Oxford
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
