Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A study to help understand why ovarian cancer can come back or continue to grow after treatment (BriTROC 1)
In this study, researchers are collecting samples from women with ovarian cancer, fallopian tube cancer and primary peritoneal cancer, to help them understand more about why chemotherapy can stop working.
The trial is for women who have
These cancers are treated in the same way, so when we use the term ovarian cancer in this summary, we are referring to all of these.
More about this trial
If you have ovarian cancer, you may have treatment with chemotherapy. But sadly this treatment does not always work, and the cancer can come back or carry on growing. Doctors in this study want to learn more about why this happens.
They will collect samples from women with ovarian cancer over time, to look at differences between tumours that come back after chemotherapy compared to when they were first diagnosed. This may help them understand why tumours stop responding (become
The researchers will also study certain areas of DNA in cancer cells called DNA repair genes. These control how well cancer cells repair damage in DNA during chemotherapy, which may affect whether a cancer shrinks. Some people can have changes (mutations) to these genes, which are passed down from their parents. The team will also look at blood samples to see how many women carry these changes, as well as at other less common genes that are linked to a risk of cancer.
The main aim of this study is to see how practical it is to collect tissue from women with ovarian cancer, so that researchers can begin to answer these questions. You will not have any direct benefit from taking part in this study, and it is unlikely to change your treatment plan in any way. But the results of the study will help women with ovarian cancer in the future.
Who can enter
You may be able to enter this study if
- You have cancer of the ovary, fallopian tube cancer or primary peritoneal cancer that has come back or continued to grow after treatment
- Your cancer is called high grade serous type or high grade endometrioid, or tests show that your ovarian, fallopian tube or primary peritoneal cancer has a change to genes called
BRCA1or BRCA2- you can ask your doctor about this
- You have had at least one
courseof platinum chemotherapybefore
- The hospital has stored a sample of your cancer from when you were diagnosed (this is routine)
- Doctors would be able take a sample of cells (biopsy) from your cancer using a CT scan or ultrasound scan to guide them (an image guided biopsy) or from any cancer surgery you may have
- You are at least 18 years old
You cannot enter this study if your blood test readings of a marker called
This study will recruit 300 women. Everyone taking part will give a number of samples for the researchers to study.
Everyone taking part will give a small sample of cancer cells (a biopsy) for the study. The team will collect this sample in one of several ways.
The doctor taking the biopsy may use a CT scan or ultrasound scan to guide them. You cannot eat or drink for several hours before this procedure. You have this biopsy using a
In some cases, it might be possible to have a biopsy using local anaesthetic that doesn't need a scan to guide it. Your doctor will tell you if this would be suitable for you.
Or, if you are having surgery, the team will take a sample when the cancer is removed.
If your cancer comes back again, the team would like to take another tissue sample and blood samples. But you can say no to this second biopsy if you want to.
The team will compare the tissue they take for the study with the stored tissue sample taken when you were first diagnosed.
Everyone will also give some samples (about 8 teaspoons) of blood to look for gene changes (mutations) that may have been passed down in your family. And, to look at DNA from your cancer in your bloodstream.
The team will also ask if you would be happy to give a blood sample before your first 2 doses of chemotherapy. These are not part of the study and you do not have to agree to them if you don’t want to.
If you have fluid that needs to be drained from your tummy (
They will also collect information from your hospital records about your previous ovarian cancer treatment and how well it worked.
You visit the hospital to have your study biopsy. You give the blood samples either the day before this, or on the same day.
If you agree to give the extra blood samples, you do this just before your chemotherapy, so you will already be at the hospital.
Side effects of biopsies include
- Mild bleeding
- Infection of the skin around the biopsy
There are a small number of more serious side effects, which are very rare, but may be life threatening. They include
- An infection in your tummy area (abdomen) called peritonitis
- Damage to the bowel
- Damage to a
Having a CT scan or an ultrasound scan to guide the procedure will greatly reduce this risk of these. You can ask the study team more about this if you want to.
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.
Professor Iain McNeish
Dr James Brenton
Cancer Research UK Clinical Trials Unit Glasgow
Experimental Cancer Medicine Centre (ECMC)
NHS Greater Glasgow and Clyde
NIHR Clinical Research Network: Cancer
Ovarian Cancer Action