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Manchester plays a key role in pioneering study that suggests screening for ovarian cancer may save lives

New results from the world's biggest ovarian cancer screening trial, involving Saint Mary's Hospital as one of 13 centres across the UK, suggest that screening based on an annual blood test may help reduce the number of women dying from the disease by around 20%.

The research, published today (Thursday) in the Lancet*, also cautions that longer follow up is needed to establish more certain estimates of how many deaths from ovarian cancer could be prevented by screening. Estimates from the results so far are promising, but the exact figures remain uncertain.

The UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS)** is an international ovarian cancer screening trial, led by UCL and funded by the Medical Research Council, Cancer Research UK, Department of Health and The Eve Appeal.

The Manchester lead for UKCTOCS and co-author of the publication was Dr Mourad W Seif, Consultant Gynaecologist at Saint Mary's Hospital and Honorary Senior Lecture at The University of Manchester.  Over 16,500 women from Greater Manchester, representing the largest group in the North West, attended regular appointments and annual screenings at the NIHR / Wellcome Trust Manchester Clinical Research Facility, a dedicated research facility at Central Manchester University Hospitals NHS Foundation Trust.

Overall, more than 200,000 post-menopausal women with no symptoms (asymptomatic) aged 50 to 74 took part in the study from across the UK. Ovarian cancer was diagnosed in 1,282 women during the 14-year study of whom 649 had died of the disease by the trial end in December 2014.

The study showed a delayed effect in mortality rates between the screening and control arms, which became significant after the first seven years of the trial. The research team are now following up the study for three more years to establish the full impact of an ovarian cancer screening programme.

The early results suggested that approximately 15 ovarian cancer deaths could be prevented for every 10,000 women who attend a screening programme that involves annual blood tests for between seven to 11 years.

The trial also confirmed previous findings that on average, for every three women who had surgery due to an abnormal screen result, one woman had ovarian cancer while two women did not. For those who had surgery, only around three per cent had major complications, which is the standard complication rate for this type of surgery in the NHS.

The screening blood test, called ROCA*** uses a statistical calculation to interpret changing levels over time of a blood protein called CA125, which is linked to ovarian cancer. This gives a more accurate calculation of a woman's individual risk of having ovarian cancer, compared with an alternative method which uses a one-off blood test measuring a fixed 'cut-off' point for CA125. The ROCA is licensed to Abcodia Ltd, a UCL spin out company. A recent publication from the same group showed that screening based on  the ROCA test will double the chance of detecting ovarian cancer  in post menopausal asymptomatic women, when compared with the cut off point.

Study Lead Investigator Professor Ian Jacobs, President and Vice-Chancellor of UNSW Australia and Honorary Professor at UCL, who co-invented the ROCA in 1996 and is also a non-executive director of Abcodia Ltd. said: "I am delighted that the UKCTOCS results suggest that early detection by screening can save lives. Longer follow up is needed but this brings hope in the fight against a disease for which the outlook for women is poor and has not improved much during the last three decades."

Dr Seif said: "The study data indicates for the first time that based on this technique, screening may reduce death from ovarian cancer.  Around 3,500 women in England die from ovarian cancer each year and ovarian cancer commonly presents in advance stages.

"We hope this discovery will lead to earlier diagnosis, before symptoms occur, and a more effective treatment for women diagnosed with the disease. I would like to thank all the women who played an important role in this study."

Barbara Slee

Barbara Slee, aged 72 from Flixton, was one of the 16,500 women who took part in the UKCTOCS study in Manchester. "It was about 11 years ago when I first signed up to the study and it was following one of my regular screening appointments in 2011 that I was diagnosed with ovarian cancer.

"Luckily for me it was caught in the early stages and I was able to have a surgical procedure. I did not have any symptoms at the time of diagnosis and if I had not been involved in the study, it may have not been picked up on. As a mother of two daughters, I can't explain how important research like this is to improve diagnosis of ovarian cancer and to help others."

Dr Fiona Reddington, Cancer Research UK's head of population research, said: "This trial has been incredibly useful in improving our understanding of ovarian cancer. Detecting it early is vital to make sure that patients have the best treatment options and that more women can survive the disease. It's uncertain whether or not screening can reduce ovarian cancer deaths overall. While this is an important step in ovarian cancer research, we would not recommend a national screening programme at this point."

-Ends-

Dr Seif is available for interview on Thursday PM and Friday.

A photo of Barabara Slee is available on request and she is available for interview on Friday.

 

To speak with Dr Seif and Barbara Slee or for further information please contact:

Emma Smith

0161 701 2679 / 0782 514 2219

Emma.smith@cmft.nhs.uk

 

Lucy Prosser

0161 701 0260 / 0782 514 2219

Lucy.prosser@cmft.nhs.uk

Notes to Editors

Central Manchester University Hospitals NHS Foundation Trust is a leading provider of specialist healthcare services in Manchester, treating more than a million patients every year. Its eight specialist hospitals (Manchester Royal Infirmary, Saint Mary's Hospital, Royal Manchester Children's Hospital [RMCH], Manchester Royal Eye Hospital, University Dental Hospital of Manchester and Trafford Hospitals) are home to hundreds of world class clinicians and academic staff committed to finding patients the best care and treatments. (www.cmft.nhs.uk)

The NIHR / Wellcome Trust Manchester Clinical Research Facility (MCRF) is a purpose-built unit focused on supporting experimental medicine research helping to bring new drugs and medical devices into patient care.  The facility is based at Central Manchester University Hospitals NHS Foundation Trust and receives funding from the National Institute for Health Research (NIHR). The MCRF offers state-of-the-art equipment and facilities for adult and children's studies, and has a team of specialist research nurses and support staff. A satellite unit the Children's CRF in the Royal Manchester Children's Hospital is at the cutting edge of research into inherited renal, metabolic, and hearing disorders.

For further information see: www.manchestercrf.wt.nihr.ac.uk

The National Institute for Health Research (NIHR) is funded by the Department of Health to improve the health and wealth of the nation through research. Since its establishment in April 2006, the NIHR has transformed research in the NHS. It has increased the volume of applied health research for the benefit of patients and the public, driven faster translation of basic science discoveries into tangible benefits for patients and the economy, and developed and supported the people who conduct and contribute to applied health research. The NIHR plays a key role in the Government's strategy for economic growth, attracting investment by the life-sciences industries through its world-class infrastructure for health research. Together, the NIHR people, programmes, centres of excellence and systems represent the most integrated health research system in the world. For further information, visit the NIHR website (www.nihr.ac.uk ).

About the NIHR Clinical Research Network
We provide researchers with the practical support they need to make clinical studies happen in the NHS, so that more research takes place across England, and more patients can take part.

This practical support includes:

  • Reducing the "red-tape" around setting up a study
  • Enhancing NHS resources, by funding the people and facilities needed to carry out research "on the ground"
  • Helping researchers to identify suitable NHS sites, and recruit patients to take part in research studies
  • Advising researchers on how to make their study "work" in the NHS environment

 

The University of Manchester, a member of the prestigious Russell Group of British universities, is the largest and most popular university in the UK. It has 20 academic schools and hundreds of specialist research groups undertaking pioneering multi-disciplinary teaching and research of worldwide significance.

The University of Manchester is one of the country's major research institutions, rated fifth in the UK in terms of 'research power' (REF 2014), and has had no fewer than 25 Nobel laureates either work or study there. The University had an annual income of £886 million in 2013/14. www.manchester.ac.uk

*Jacobs, Menon et al., 'Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial' will be published in The Lancet at 12 noon UK time on Thursday 17 December. The authors will be holding a public meeting about the trial results to coincide with the publication. Event details, including a link to live stream the event, are available at the following URL: http://www.ucl.ac.uk/live/ukctocs

**The trial involved 202,638 post-menopausal women aged 50 to 74 who were randomly assigned to annual multimodal screening using the Risk of Ovarian Cancer Algorithm (ROCA), annual transvaginal ultrasound, or no test.

Initial analysis of the results across the 14 years of the trial found a reduction in ovarian cancer mortality due to screening that did not reach statistical significance. However, after further analysis that allowed for the delay between entry into the trial and developing the disease, and excluding women with evidence of already having ovarian cancer at entry, the statistically significant results suggest that screening reduces the number of women dying of ovarian cancer by around 20% over the 14 years of the study. The study allows us to be almost certain that screening reduces the number of women dying from ovarian cancer by somewhere between 0% and 40%, so further follow up is required to narrow this estimate.

***Based on the ROCA test score, a woman's risk is categorised as either normal - where she should continue with annual screening; intermediate - requiring a repeat blood test in 3 months or elevated - where a repeat blood test is required along with and a transvaginal ultrasound in 6 weeks.

The ROCA has been licensed to Abcodia Ltd., a UCL spin out company. UCL is a major shareholder and CRUK have a small shareholding. Professor Jacobs is an Abcodia shareholder and Non-Executive Director and Professor Usha Menon is an Abcodia shareholder. As co-inventors Dr Skates and Professor Jacobs will receive a share of the ROCA royalties from MGH and QMUL. Following an agreement with UCL, Abcodia has provided research funding to the Gynaecology Cancer Research Centre at UCL directed by Professor Menon since 2011 for the purpose of maintaining and accessing the UKCTOCS biobank. Abcodia acquired the ROCA license in 2014 from MGH and QMUL and has in late 2015 started offering the test in the UK and USA. In order to obtain expert advice on the use of the ROCA, Abcodia has agreed to pay for consultancy roles with members of the UKCTOCS team: Professor Ian Jacobs (University of New South Wales, UCL, University Of Manchester); Dr Steven Skates (MGH); Dr Anne Dawnay (UCLH); Dr Mourad Seif (University of Manchester and St Mary's Hospital).

National survival statistics for ovarian cancer are summarised on the Cancer Research UK website: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/ovarian-cancer/survival#heading-Zero

 

UKCTOCS is the world's largest ovarian cancer screening trial. 1.2 million women across England, Wales and Northern Ireland were invited to participate. 202,638 postmenopausal women aged between 50 and 74 years who did not have a strong family history of ovarian cancer were recruited through 13 participating NHS Trust from 2001-2005. They were randomly allocated to three groups: multimodal screening (50,640) or transvaginal ultrasound (50,639) who underwent annual screening until December 2011; or to a control group (101,359) who were not screened. Annual screening continued until December 2011. The control group is in accordance with current NHS guidelines as there is no evidence at present to support an ovarian cancer screening programme. All women are being followed up. http://www.instituteforwomenshealth.ucl.ac.uk/womens-cancer/gcrc/ukctocs

 

The trial is being run from the Gynaecological Cancer Research Centre, Women's Cancer, UCL EGA Institute for Women's Health. It was funded by the Medical Research Council, Cancer Research UK and Department of Health and is supported by gynaecological cancer research charity The Eve Appeal and the National Institute for Health Research University College London Hospitals Biomedical Research Centre.

 

Since 2009, the study has been managed on behalf of the principal funders through the  EME Programme (an MRC and NIHR partnership) and has also received support from the NIHR University College London Hospitals Biomedical Research Centre through staff support (programmed activities) and infrastructure for add-on research. The study also received support from the NIHR Clinical Research Network.