A study looking at a new blood test to find cancer early (MODERNISED)
Cancer type:
Status:
Phase:
This study is looking to see if a new blood test can help to spot cancer early.
The study is for people who have been diagnosed with certain types of cancer. It is also for people who have signs and symptoms of these cancer types.
The study is open for a number of different cancer types. Look in 'who can enter' to find out which cancer types.
The team also asked some people who were fit and well and didn’t have cancer (healthy volunteers) to join. This part is now closed to recruitment.
More about this trial
When doctors find cancer at an early stage, there is a better chance of treating it with the aim to cure. Researchers are looking for new ways to detect cancer early.
The Enlighten test is a new blood test. It is a type of multi cancer early detection (MCED) test. Enlighten looks at the levels of certain proteins found in blood. Some cells of the immune system can recognise cancer cells as abnormal and kill them. You might hear this called an immune response. We know that in the earliest stages of cancer, the body’s immune response can lead to higher levels of these proteins being released. Researchers think that this may be a useful way to test for early signs of cancer.
The team will use the test to look at the immune system in people who have cancer. They will compare this with people who haven’t been diagnosed with cancer but have symptoms. They will also look at the immune system in some people who are fit and well, and don’t have cancer.
Researchers aren’t sure how well the test will work. So they are doing this study to find out how accurate it is.
In this study, everyone taking part has one blood sample taken.
The aim of this study is to find out how good the Enlighten test is at detecting cancer early.
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
For people with cancer or who might have cancer
You have recently been diagnosed with, or your doctor suspects you have, one of the following cancers:
- breast cancer
- melanoma skin cancer
- bowel cancer
- lung cancer
- prostate cancer
- pancreatic cancer
- ovarian cancer
- cancer of the food pipe (oesophagus)
- kidney cancer
- bladder cancer
As well as the above, all of the following must also apply. You:
- are willing to have a blood sample taken when you join the study
- are at least 18 years old
Who can’t take part
You cannot join this study if any of these apply. You:
- have already had treatment for cancer
- have had another cancer in the past. This doesn’t apply to the cancer or suspected cancer as part of this study.
- are unwell and have a high temperature
- have had an infection and were admitted to hospital within 30 days of having the blood sample taken
- have an inflammatory condition that has got worse and needed treatment within 14 days of having the blood sample taken
- have had surgery or a tissue sample taken (
biopsy 
) within 14 days of having the blood sample taken - have had a blood transfusion within 30 days of having the blood sample taken
- have had an
organ transplant or a stem cell transplant with somebody else’s stem cells in the past - have had steroid treatment within 14 days of having the blood sample taken
- aren’t well or you can’t have a blood sample taken
- are pregnant or have been pregnant
Trial design
The team need 1,350 people to take part in this study. This includes:
- 1,000 people who have been diagnosed with cancer
- 250 people who have signs and symptoms of cancer but haven’t been diagnosed with cancer
- 100 people who are fit and well (healthy volunteers). Please note, this part is closed to recruitment.
For people who have cancer or possible symptoms of cancer
At your hospital appointment, a member of the research team will ask if you would like to take part. They will tell you about the study and check if you are suitable for it. You sign a if you agree to join. The team then check your medical records and ask you some questions about your health.
They also ask:
- your age, sex and ethnicity
- about your level of education
- what job you do
- about your income
Healthy volunteers – this group is closed to recruitment
This group of people were asked:
- their age, sex and ethnicity
- about their level of education
- what job they do
- about their income
Blood sample for both groups
Everyone has a blood sample taken. You will not find out the results of the blood test. The research team can explain to you why you won’t get the results.
The team will ask your permission to store some of the blood sample for future research. You don’t have to agree to this.
Follow up
The study team check everyone’s medical records and NHS . They do this for up to 2 years after you join the study.
They would like to collect information on:
- the results of tests and appointments you have
- any treatment you may have if you have cancer
- any cancer diagnosis
Hospital visits
You won’t have an extra hospital visit if you have cancer or have possible symptoms of cancer. The research team will catch up with you at one of your routine hospital appointments.
Side effects
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 a little bruise
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
Professor Andrew Davies
Supported by
Cancer Research UK Clinical Trials Unit, Southampton
University Hospital Southampton NHS Foundation Trust
National Institute for Health and Care Research (NIHR)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
