A study using a blood sample to diagnose cancer (PREVAILctDNA)
Cancer type:
Status:
Phase:
This study is looking at whether a blood test can help to diagnose cancer. The test is looking for small pieces of 
that cancer cells release into the blood.
It was open to people with a number of different cancer types. It is now open to people with a coupe of cancer types. To find out which cancer types these are look in 'who can enter’.
More about this trial
There are standard tests and scans doctors use to diagnose cancer. Some tests include taking tissue samples (). There are different ways the doctor can do the biopsy. This often involves a procedure where the doctor puts a tube into an opening in your body such as a:
All of these involve taking tissue samples from any abnormal looking areas. To do this the doctor uses a needle that is guided by a scan such as an or .
Taking the biopsy this way increases the likelihood that body fluids from these openings can spray out as fine droplets. For example saliva from the mouth when you have the procedure. This is a natural and uncontrollable reflex. And sometimes this can be a concern. For example during the COVID-19 pandemic.
It may also be that some cancers are in a position in the body that makes it very difficult to get a biopsy.
So researchers are looking for a way to diagnose cancer without having to do these procedures.
We know that some cancers shed their DNA into the bloodstream. This is called circulating DNA (). Researchers think they could use the ctDNA to help diagnose cancer.
They will try to find this out by taking blood samples and testing them for ctDNA. The team will compare the results of the ctDNA test with the standard tests and scans you have.
This study is in 2 parts. In the 1st part the team will look at using ctDNA in the everyone who takes part. In the 2nd part the team will look at whether ctDNA can help with the diagnosis and treatment for pancreatic and bile duct cancer.
The aims of part 1 of the study are to find out:
- the number of people that ctDNA shows up in people who might have cancer
- whether ctDNA can help diagnose cancer
The aims of part 2 of the study are to find out whether ctDNA can help to:
- diagnose and treat suspected pancreatic cancer and bile duct cancer
- improve the waiting times for people with pancreatic cancer and bile duct cancer
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 part 1
You may be able to join part 1 of the study if you have had a tissue sample taken (biopsy). And you are waiting for a diagnosis of one of the following:
- bowel cancer that has spread to a new area of the body (metastatic)
- gastrointestinal stromal tumours (GIST)
You might be able to join if you have a diagnosis of one of the following cancers. And you are waiting for a gene test result or there wasn’t enough of the tissue sample taken to do a gene test. The cancers are:
- bowel cancer that has spread
- GIST
For part 2
You may be able to join part 2 of the study if you have pancreatic cancer or bile duct cancer and all the following apply.
- You are in the ACCESS implementation programme. Your doctor will know this.
- The Guardant360 test detected ctDNA. Your doctor will know this.
- The ctDNA is consistent or diagnostic with a diagnosis of pancreatic cancer or bile duct cancer. Your doctor will know this.
For both parts
Both of following must apply. You:
- are well enough to have treatment
- are at least 18 years old
Who can’t take part
For part 1
You cannot join this study if you have had a diagnosis from a biopsy and you can have the .
For part 2
You have had another or a blood cancer such as leukaemia, lymphoma or myeloma in the past 3 years.
Trial design
The team need 144 people to join part 1. And 150 people to join part 2.
You have the standard tests and scans to diagnose your cancer.
You give blood samples for the study. The team take all the samples they need at one time. They use the samples to look for small pieces of cancer DNA (ctDNA) in the blood.
Your doctor will get the results of the ctDNA. They will discuss them with you.
If you have surgery or a tissue sample (biopsy) taken the team will look in your medical records for the results. They want to see if those results match the ctDNA results.
Occasionally the team might find gene changes () that run in the family (). Some of these mutations may mean that members of your family are at an increased risk of developing cancer. Your doctor will discuss this with you. They might offer to refer you to a healthcare professional that specialises in genes and cancer (a geneticist) to discuss this further.
You stay in the study until you have a treatment plan. You and your doctor decide your treatment plan.
Hospital visits
There are no extra hospital visits in this study.
Side effects
There is a small risk that the results of the ctDNA test are not accurate. You will have the standard tests and scans to help with diagnosing whether you have cancer or not.
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 Naureen Starling
Supported by
The Royal Marsden NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
