RecruitingOBSERVATIONAL

Transforming Ovarian Cancer Diagnostic Pathways

This study, called SONATA, is investigating a new way to diagnose ovarian cancer earlier. Currently, doctors use a blood test called CA125, but it can miss some early cancers. The new test, called ROMA, uses two blood markers, CA125 and HE4, and may be better at spotting ovarian cancer, especially in its early stages. We want to compare ROMA with CA125 to see which is more accurate and cost-effective for women visiting their GP with symptoms that could be ovarian cancer. If your GP orders a CA125 test, your blood will also be checked for HE4 to calculate ROMA, without any extra steps needed from you. This research aims to help doctors find ovarian cancer sooner, which can greatly improve treatment success.

At a glance

Status

Recruiting

Sponsor

Professor Sudha Sundar

Enrolment target

34,000

Start

23 Jan 2024

Estimated completion

31 Jul 2025

Ovarian Cancer

What is this study about?

When ovarian cancer is found early, a woman's chances of surviving for five years are much higher – around 90%. However, if it's found later, these chances drop significantly. At the moment, when a woman goes to her GP with symptoms that might suggest ovarian cancer, the doctor usually orders a blood test called CA125 and sometimes an ultrasound scan. The problem is, the CA125 test alone can miss half of early-stage ovarian cancers, meaning some women aren't diagnosed as quickly as they could be.

This study is looking at a newer blood test called ROMA (Risk of Malignancy Algorithm). This test combines the CA125 result with another blood marker called HE4. Scientists in other countries like the US and Europe already use ROMA, and research suggests it might be better than CA125 at finding ovarian cancer, especially at an early stage. However, most of this research was done in hospitals, where more advanced cancers are often seen. We need to check if ROMA works just as well for women who are first seen by their GP.

For this new test to be used more widely in the NHS, we need to prove that it is accurate for women attending their GP and that it offers good value for money. This study is part of a bigger project called SONATA, which aims to improve how ovarian cancer is diagnosed right from the GP surgery to specialist care. Two large NHS labs will test an extra 41,000 blood samples from women whose GPs have already ordered the CA125 test. We will then compare the results of ROMA and CA125 to see if ROMA can indeed help doctors find more cancers earlier.

Key takeaways

This study aims to find ovarian cancer earlier.
It compares a new blood test (ROMA) with the current one (CA125).
ROMA combines CA125 with another marker, HE4.
Results could improve future ovarian cancer diagnosis for all women.
Participation involves no extra tests or visits for you.
You won't receive individual ROMA results from the study.

Who may be eligible?

This study is for women who are visiting their GP because they have symptoms that could potentially be ovarian cancer. To be included, your GP would typically order a blood test called CA125 as part of the usual checks for these symptoms.

It's important that your GP suspects ovarian cancer or is checking for it, which is why they would order the CA125 test. Your participation is based on this standard procedure your GP would follow anyway.

You would not be eligible if you don't have symptoms that sometimes suggest ovarian cancer, or if your GP suspects ovarian cancer but doesn't order the CA125 blood test for another reason.

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 am a woman.
I am attending my GP because I have symptoms that could be ovarian cancer.
My GP has decided to order a CA125 blood test for me.
I understand my participation won't change my current care.
I understand I won't get my individual ROMA test results.

Answer every question to see your result.

What does participation involve?

Taking part in this study is very straightforward and doesn't require any extra steps from you. If your GP decides to order a standard CA125 blood test because they are checking for symptoms that might suggest ovarian cancer, the blood sample you provide for that test will also be used to check for the HE4 marker. This HE4 result will then be combined with your CA125 result to calculate the ROMA score. This happens automatically in the lab; you won't need to give any additional blood or have any extra appointments. The study is simply looking at your routine blood test results in a new way to help improve future diagnosis for other women.

Potential risks and benefits

There are no direct benefits or risks to you as an individual for taking part in this study. Your treatment will be based on the usual care your GP provides, and the research will not impact your diagnosis or care in any way. You will not receive your ROMA result because the study is designed to evaluate a potential future diagnostic pathway, not to inform individual patient management in real-time. The information gathered will be used to improve ovarian cancer diagnosis across the NHS for other women in the future. You always have the right to withdraw from the study at any time, which means your anonymous data will no longer be used for the research.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Sandwell and West Birmingham NHS TRUST
Verified postcode
Birmingham, United Kingdom· Not yet recruiting
Gateshead Health NHS Foundation Trust
Verified postcode
Gateshead, United Kingdom· Recruiting
The Royal Wolverhampton NHS Trust
Verified postcode
Wolverhampton, United Kingdom· Recruiting

Common questions

What is ovarian cancer?

Ovarian cancer is a type of cancer that starts in the ovaries, which are part of a woman’s reproductive system.

What is CA125?

CA125 is a protein in the blood that can be higher in women with ovarian cancer, but also in other conditions. It's currently used to help doctors decide if someone needs further tests.

What is ROMA?

ROMA stands for 'Risk of Malignancy Algorithm'. It's a calculation that uses the results of two blood tests, CA125 and HE4, to give a score that might better show the risk of ovarian cancer.

Will I get my ROMA result?

No, you will not receive your ROMA result. This study is for research purposes to see if the test works well, not to give you an individual diagnosis based on ROMA at this stage.

Do I need to do anything extra if I take part?

No, you don't need to do anything extra. If your GP orders a CA125 blood test for you, your sample will automatically be included in the study to check for HE4 as well, without any extra steps or appointments for you.

How to find out more

Sudha Sundar

s.s.sundar@bham.ac.uk +441214144477 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.