ROCkeTS GEN V2 Study. Refining Ovarian Cancer Test Accuracy Scores: A test accuracy study to validate new risk scores in postmenopausal women with symptoms of suspected ovarian cancer
The ROCkeTS GEN V2 study is looking for better ways to spot ovarian cancer earlier in women who have gone through menopause. Many women experience symptoms like bloating or have ovarian cysts, or a high CA125 blood test, which can sometimes (but not often) be a sign of ovarian cancer. This study wants to improve existing tests to tell the difference more accurately. By doing this, we hope to reduce unnecessary trips to the hospital and distress for women who don't have cancer, while also making sure those who do have cancer get diagnosed sooner. Participants will provide blood samples and, if they have surgery, a small tissue sample.
At a glance
What is this study about?
Many women experience symptoms like feeling bloated, uncomfortable tummies, or have small balloon-like swellings (cysts) on their ovaries found during an ultrasound scan. Some women also have higher levels of a blood marker called CA125. It's important to know that these can be signs of many different things, and only a very small number of women with these symptoms or test results will actually have ovarian cancer.
This study, called ROCkeTS GEN V2, aims to find better and more accurate tests for women who have gone through menopause and have these symptoms or abnormal test results. The main goal is to detect ovarian cancer earlier when it's easier to treat. We also want to reduce the number of women who have to go through extra tests, hospital visits, and a lot of worry when they don't actually have cancer. By finding better ways to tell the difference, we hope to make the process less stressful and more effective for everyone.
To achieve this, the study will gather information and test samples from women who are being investigated for possible ovarian cancer. This will help researchers develop and check how well brand new tests work compared to the ones currently used. Ultimately, the results of this study could lead to significant improvements in how ovarian cancer is detected and managed in the future for women across the UK.
Key takeaways
- A UK study for postmenopausal women with suspected ovarian cancer.
- Aims to find better and earlier detection tests for ovarian cancer.
- Involves answering questions, blood samples, and possibly a tissue sample if surgery is needed.
- Does not change your current medical care; no extra hospital visits.
- Helps improve future care for other women; potential for minor bruising from blood draw.
- Funded by Cancer Research UK and coordinated by the University of Birmingham.
Who may be eligible?
This study is looking for women who have gone through menopause. This means you haven't had a period for over 12 months. If you no longer have periods for other reasons, like using certain contraception or having a hysterectomy (womb removal), your menopausal status will be decided based on your age.
You should also have symptoms that have led your doctor to suspect ovarian cancer and have been sent to a specialist. In addition, you must have one of the following: a high CA125 blood test result, or an abnormal scan showing something on your ovary, or both.
You cannot take part if you are still having periods, have very small simple ovarian cysts (under 5cm) without a raised CA125, have had ovarian cancer before, or have certain other active cancers (unless you completed treatment over a year ago or have specific non-cancerous conditions).
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I have gone through menopause (no period for over 12 months).
- I have symptoms that led my doctor to suspect ovarian cancer and referred me to a specialist.
- I have either a high CA125 blood test, an abnormal scan on my ovary, or both.
- I have not had ovarian cancer before.
- I do not have certain other active cancers (or finished treatment over a year ago).
What does participation involve?
If you decide to take part in this study, you will be asked to answer a few questions about your symptoms. You will also be asked to give a small blood sample, which is about two tablespoonfuls (30 ml). Additionally, a few drops of blood will be collected from a finger prick. If it's decided that you need surgery, a tiny piece of tissue will also be collected during the operation. There will be no extra clinic visits purely for the study.
Potential risks and benefits
Locations (1)
- City HospitalApproximateBirmingham, England
Common questions
What is CA125?
CA125 is a protein that can be found in your blood. Higher levels can sometimes be linked to ovarian cancer, but it can also be raised because of many other common conditions, like periods, fibroids, or infections.
What does 'postmenopausal' mean?
It means you have naturally stopped having your monthly periods for at least 12 months.
Will this study change my current medical care?
No, your participation in this study will not change the medical care you receive from your doctors. The study is about developing better tests for the future.
How much blood will be taken?
You will be asked to provide two types of blood samples: about two tablespoonfuls (30ml) of blood from your arm, and a few drops (around 0.1-0.2ml) from a finger prick.
When will the results of the study be ready?
The study aims to finish collecting data and analysing it by 2029, so results won't be available until after then.
How to find out more
Sudha Sundar
Always speak to your GP or specialist before deciding to take part in a study.
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