£2m study aims to improve early stage ovarian cancer diagnosis

A £2 million study will see an advanced test used at GP surgeries in the West Midlands to diagnose early-stage ovarian cancer – potentially saving thousands of lives a year.

The project involves BHP members Sandwell and West Birmingham (SWB) NHS Trust and the University of Birmingham collaborating with Walsall Healthcare NHS Trust (WHT) and primary care provider Modality, to offer a blood test called ROMA to patients experiencing symptoms of ovarian cancer.

Signs of the disease include bloating, stomach pain, needing to urinate more often and always feeling full.

If symptoms persist or are severe, frequent or out of the ordinary, women are urged to see their GP where – usually – a CA-125 blood test will be carried out, which has around a 50% detection rate of early-stage cancer.

However, the advanced ROMA test used during this trial at Modality-run GP services in Walsall, Sandwell and West Birmingham, will identify key markers of this particular disease at an earlier stage.

If a patient has tested positive, they will be referred to their local Trust to attend a new one stop clinic where they’ll see a consultant, undergo a specialist scan and then a further consultation where the results will be shared. They will be referred for further treatment if needed.

Speaking about the study, called SONATA (tranSforming Ovarian caNcer diAgnostic paThwAys), Sudha Sundar, Professor of Gynaecological Cancer at the University of Birmingham and Consultant Surgeon at SWB NHS Trust, said: “Ovarian cancer is rare and there is a need to increase the understanding and awareness of the symptoms associated with it among our population and GPs.

“We know that 90% of women diagnosed with ovarian cancer at stage one will survive, but this drops drastically to 15% if it is picked up during stage four.

“Research conducted with my team at the University of Birmingham found out that the ROMA test is significantly better than current tests (CA125 and ultrasound) used in both pre and postmenopausal women*.

“A previous study had found that the ROMA test detects up to 20% more early-stage cancers than the current test which only picks up 50% of early-stage cancers**. We are putting this research into practice by carrying out this trial.”

“With Modality-run GP surgeries trialling the ROMA test we will be able to establish if it is acceptable to patients and clinicians. By testing many samples across two large laboratories, we will be able to confirm whether the ROMA test has a higher chance of detecting this cancer earlier than the current CA-125 blood test used and whether implementing this across the NHS will be cost-effective.”

Leading on the project, Dr Aamena Salar, medical director for Modality Partnership Community Services, said: ‘Our aspiration is to transform the care of ovarian cancer by earlier detection and better outcomes for our patients.”

Nina Jhita, programme director at Modality, added: “This is true innovation; we (primary care) are delighted to collaborate with key system partners across the West Midlands to really make a difference to the lives of women while demonstrating how this solution can be scaled across the UK.”

The final part of the study will see 41,000 primary care samples sent to the Black Country Pathology Service and South Tyne and Wear laboratories to accurately establish whether using the ROMA test rather than CA125 will be cost effective for the NHS. The results from the study, funded by the NHS Cancer Programme and the Small Business Research Initiative, will be analysed and used to change the way this cancer is diagnosed in the future.

Professor Sundar added: “It’s an exciting study which is a great example of integrated working between all the organisations involved. We are looking forward to finding out the results so that we can change the way this cancer is detected in the future and drastically improve survival rates.”

*Abstract published in July 2023: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD011964.pub2/full
**Further information can be found here: https://pubmed.ncbi.nlm.nih.gov/27540691/