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Research offers hope for early detection of ovarian cancer

11 March 2009

The first analysis of screening for ovarian cancer currently being investigated by the UKCTOCS (UK Collaborative Trial of Ovarian Cancer Screening) trial, which includes research at Cardiff University, is published in Lancet Oncology.

Preliminary results from UKCTOCS show that in the first screen of the 100,000 women participating in the screening arms of the trial, screening detected ovarian cancer or borderline tumours in 87 women and missed picking up 13 women who went on to develop the disease within a year of screening. Almost half (48%) of the 58 cancers detected were at an early stage. The Lancet Oncology paper does not report on cancers in the 100,000 women included in the control arm of the trial who are not being screened; this is in accordance with current NHS guidelines as there is no ovarian cancer screening programme. Cancers that developed in women in the screening arms in the subsequent years of the study are not reported in this first analysis.

Cardiff is one of 13 research centres taking part in the study across the UK, co-ordinated by University College London. Working with colleagues at the University Hospital of Wales, Cardiff researchers have screened more than 16,000 women

Mr Nazar Amso, of the Department of Obstetrics and Gynaecology at the School of Medicine, Cardiff University, is leading the Cardiff contribution. He said: "This is the largest-ever trial of its kind into ovarian cancer. We are very grateful to all the women in Wales who have taken part so far. The trial still has five years to run and there is much to be done before we have firm evidence whether screening can detect ovarian cancer early enough to save lives."

Ovarian cancer is most common in women who have gone through menopause, and diagnosis is usually when cancer is already in the advanced stages. Women from 27 Primary Care Trusts in England, Wales and Northern Ireland were asked to join the study. All of the 200,000 women recruited to the trial between 2001 and 2005 through the 13 participating NHS Trusts were postmenopausal and aged between 50 and 74 years old. Following the initial screen, reported in this Lancet paper, women are continuing to be invited for further screening until 2011. Everyone will be followed up until December 2014.

Two screening methods are being used in the UKCTOCS trial: a blood test or an ultrasound scan. The blood test measures levels of a protein called CA125 that is often elevated in the blood of women who have ovarian cancer. The research team used statistics to determine risk of ovarian cancer based on the woman’s age, how much CA125 was present and how the level changed with time. The ultrasound scan is used to look for abnormalities in the ovaries. Approximately 50,000 women were allocated to screening using the blood test and a further 50,000 to ultrasound to measure the efficacy of these screening methods.

If a volunteer’s blood test result suggested risk of ovarian cancer, the woman was recalled for additional screening and follow up; 97 had surgery to remove the ovaries and 42 women with ovarian cancer were identified in this group.

Women in the ultrasound group who were found to have persistent abnormalities were referred for a specialist opinion; 845 had surgery to remove the ovaries and 45 women with ovarian cancer were identified in this group. The research team found both methods of screening were encouragingly sensitive. Almost half the cancers detected were at an early stage (I or II).

The research team suggest that the higher number of repeat tests and surgical procedures in the ultrasound group could be attributed to the number of older women who have benign ovarian cysts which are detected by ultrasound. A proportion of these women have to undergo surgery and examination of the ovarian tissue before diagnosis of ovarian cancer can be ruled out.

The study is being run from the Gynaecological Cancer Research Centre, UCL Institute for Women’s Health. As the trial progresses, researchers will continue to monitor how many of the 202, 638 women develop ovarian cancer. In the 101,000 undergoing screening the team will monitor how many of cases of cancers are detected and at what stage. They will also record how many women have surgery.

Dr Usha Menon, UKCTOCS trial co-ordinator and one of the principal investigators said: "These results are extremely encouraging. We’d like to thank all of the women involved in the trial and to encourage them to continue helping us by attending for screening until the end of the trial. The early results suggest that both types of screening can be used on a large scale and both successfully identify ovarian cancers. However, we must wait till 2015 before we can conclude whether or not a wider screening programme could lead to a fall in deaths due to ovarian cancer."

The UKCTOCS trial has been funded by the Medical Research Council, Cancer Research UK and the National Institute for Health Research and is supported by gynaecological cancer research charity The Eve Appeal.

Lead investigator Professor Ian Jacobs, director of the UCL (University College London) Institute for Women’s Health concluded: "I believe the UKCTOCS trial is an example of UK healthcare at its best. It is a combination of a huge research effort, involving charity, research council and Government funders, hospital staff, university researchers and GPs around the UK and crucially more than 200,000 women. The first results are an important step forward and the trial itself is a powerful demonstration of how our best scientists, clinical researchers and healthcare workers in the UK collaborate in research and involve volunteers nationwide to improve health.’’

Further Information:

Nazar N Amso PhD (London) FRCOG

Fellow of the Higher Education Academy

Senior Lecturer

Department of Obstetrics & Gynaecology

School of Medicine

Cardiff, CF14 4XN

02920 744 448

AmsoNN@cardiff.ac.uk

Stephen Rouse,

Public Relations Office,

Cardiff University.

029 2087 5596

e-mail: RouseS@cardiff.ac.uk

Original research paper: Sensitivity and specificity of multimodal and ultrasound screening for ovarian cancer, and stage distribution of detected cancers: results of prevalence screen of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) is published in Lancet Oncology.

UKCTOCS trial website: http://www.ukctocs.org.uk/

Background info on ovarian cancer

March is ovarian cancer awareness month

Information about ovarian cancer on the Cancer Research UK Cancer Help website

Information about ovarian cancer on the Eve Appeal website

Ovarian cancer is the fourth most common cause of cancer death in UK women with nearly 7,000 women diagnosed annually and 4,500 women dying every year from the disease. Women diagnosed in the later stages (stage III or IV) of ovarian cancer have a survival rate of 30 per cent, compared to 80-90 per cent of those diagnosed in stages I/II. The hope is that screening to diagnose ovarian cancer at an earlier stage can improve these poor survival rates.

Early detection of ovarian cancer is complex as signs and symptoms of ovarian cancer are easily mistaken for other, more common and less serious conditions. The average GP only sees one case of ovarian cancer every five years. The Department of Health has recently issued two sets of guidance on signs and symptoms of ovarian cancer - one for members of the public (October 2008) and the other for health professionals (February 2009).

Cardiff University

Cardiff University is recognised in independent government assessments as one of Britain’s leading teaching and research universities and is a member of the Russell Group of the UK’s most research intensive universities. Among its academic staff are two Nobel Laureates, including the winner of the 2007 Nobel Prize for Medicine, Professor Sir Martin Evans.

Founded by Royal Charter in 1883, today the University combines impressive modern facilities and a dynamic approach to teaching and research. The University’s breadth of expertise in research and research-led teaching encompasses: the humanities; the natural, physical, health, life and social sciences; engineering and technology; preparation for a wide range of professions; and a longstanding commitment to lifelong learning.

Visit the University website at: www.cardiff.ac.uk

About the Medical Research Council

The Medical Research Council is dedicated to improving human health through excellent science. It invests on behalf of the UK taxpayer. Its work ranges from molecular level science to public health research, carried out in universities, hospitals and a network of its own units and institutes. The MRC liaises with the Health Departments, the National Health Service and industry to take account of the public’s needs. The results have led to some of the most significant discoveries in medical science and benefited the health and wealth of millions of people in the UK and around the world. www.mrc.ac.uk

Cancer Research UK

• Together with its partners and supporters, Cancer Research UK's vision is to beat cancer.

• Cancer Research UK carries out world-class research to improve understanding of the disease and find out how to prevent, diagnose and treat different kinds of cancer.

Cancer Research UK ensures that its findings are used to improve the lives of all cancer patients.

• Cancer Research UK helps people to understand cancer, the progress that is being made and the choices each person can make.

• Cancer Research UK works in partnership with others to achieve the greatest impact in the global fight against cancer.

For further information about Cancer Research UK's work or to find out how to support the charity, please call 020 7009 8820 or visit www.cancerresearchuk.org.uk

About the National Institute for Health Research

The National Institute for Health Research provides the framework through which the research staff and research infrastructure of the NHS in England is positioned, maintained and managed as a national research facility. The NIHR provides the NHS with the support and infrastructure it needs to conduct first-class research funded by the Government and its partners alongside high-quality patient care, education and training. Its aim is to support outstanding individuals (both leaders and collaborators), working in world class facilities (both NHS and university), conducting leading edge research focused on the needs of patients. http://www.nihr.ac.uk

About the UCL Elizabeth Garrett Anderson Institute for Women’s Health

The Gynaecological Cancer Research Centre is part of the UCL Elizabeth Garrett Anderson Institute for Women's Health, a joint venture between UCL (University College London) and University College London Hospitals NHS Foundation Trust (UCLH). It brings together individuals with expertise across the whole spectrum of women's health - from laboratory science to clinical skills to social and behavioural sciences - with the objective of making a major contribution to the health of women, both in the UK and internationally, by pioneering research, education programmes and clinical initiatives. http://www.instituteforwomenshealth.ucl.ac.uk

About the Eve Appeal

The Eve Appeal fundraises for the vital research into ovarian cancer undertaken by the Gynaecological Cancer Research Centre at UCL, whose team lead and coordinate the UKCTOCS trial. For further information; to read the Department of Health guidance on signs and symptoms or to support the work of The Eve Appeal please visit www.eveappeal.org.uk

Further background information about the UKCTOCS trial

UKCTOCS Regional Centres

Co-ordinating Centre

Gynaecological Cancer Research Centre,

Institute for Women’s Health,

University College London Regional Centres Start date Recruitment Collaborators

Queen Elizabeth Hospital Gateshead

18-04-2001 17,323 Mr Keith Godfrey (previously Mr Tito Lopez)

St Bartholomew’s Hospital London - St Bart’s

17-06-2001 19.834 Ms Usha Menon & Mr David Oram

Liverpool Women’s Hospital Liverpool

16-07-2001 10,097 Mr Jonathan Herod

Nottingham City Hospital Nottingham

23-07-2001 16,781 Ms Karin Williamson

St Mary’s Hospital Portsmouth

11-09-2001 19,191 Mr Robert Woolas

The Royal Free Hospital London - Royal Free

22-10-2001 16,830 Mr Tim Mould

St Michael’s Hospital Bristol

24-10-2001 16,538 Mr John Murdoch

Belfast City Hospital Belfast

11-03-2002 13,584 Mr Stephen Dobbs

Cardiff University Cardiff

22-04-2002 16,758 Mr Nazar Amso

Llandudno General Hospital N. Wales - Llandudno

27-05-2002 14,338 Mr Simon Leeson

St Mary’s Hospital Manchester

10-06-2002 16,518 Mr Mourad Seif

Derby City Hospital Derby

16-09-2002 14,920 Mr Howard Jenkins (previously Mr Ian Scott)

The James Cook University Middlesbrough

10-02-2003 9,926 Mr Derek Cruikshank

Total 202,638

Other studies being undertaken in UKCTOCS

Innovative approaches were used in UKCTOCS to recruit more than 200,000 women as reported in a paper published in the BMJ. (Menon,U. et al. Recruitment to multicentre trials--lessons from UKCTOCS: descriptive study. BMJ 2008, vol 337, pp1283-6).

Women participating in UKCTOCS have been very generous and given permission for their data and samples to be used in other secondary research studies.

Several of these are underway and some have reported, including

o Trends in HRT use among the women who joined UKCTOCS showed that there was a steady decline in use throughout the recruitment period. This is thought to be due to the premature closure of HRT trials and the ensuing publicity. The study was published in the journal Menopause in 2007 (U. Menon et al for the UKCTOCS group. Decline in use of hormone therapy among postmenopausal women in the United Kingdom. Menopause volume 14: pp462-67).

o Managing menopausal symptoms (MMS) is a survey asking UKCTOCS women in depth how they manage their menopause, whether they are using any non-HRT treatments to cope with the symptoms and their attitudes to these treatments. Questionnaires were sent to 11,000 women who volunteered to participate in this and analysis is underway to assess level of use, and potential benefit, of over-the-counter remedies such as black cohosh or dietary and lifestyle changes. This is a little studied area as it falls outside standard clinical practice.

o A valuable component of the trial is that the serum bank contains samples from volunteers that will precede a diagnosis of cancer. Collaborative projects with other research groups are underway using serum samples collected from UKCTOCS volunteers to try to find better predictive markers initially in ovarian, breast and pancreatic cancers. It is hoped that the bank will help in the development/ validation of blood tests for new protein markers that can detect cancers earlier.

o A similar study is also underway exploring the role of both epigenetic and hormonal changes in serum for the prediction and early detection of breast cancer. Epigenetics is the study of heritable changes in gene function that occur without a change in the DNA sequence.

o The role of USS measurement of the thickness of the lining of the womb in early detection of endometrial cancer is being analysed using data collected in women in the USS group.

o A PhD project is underway in the USS group to determine whether the presence of tiny ovarian inclusion cysts which occur in around 2% of healthy postmenopausal women is associated with any increased risk of developing breast, ovarian or endometrial cancer.

o It has become clear that the number of deaths from common diseases including cancer is lower in the UKCTOCS volunteers than we would expect from UK population statistics. We believe this is because people who volunteer to take part in trials like UKCTOCS tend to be better informed about health issues and are less likely to have unhealthy habits, such as smoking. We are clarifying this ‘healthy volunteer effect’ and will report our findings as they have significant impact on the design of future clinical trials.

o A prospective survey of symptoms in 100,000 women participating in UKCTOCS is underway. Follow up will help assess if symptoms can help us diagnose ovarian cancer earlier in women.

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