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Institute Director

Peter Brocklehurst

Professor
Peter Brocklehurst




Director of the Institute for Women’s Health at UCL and Co-Director of the Department of Health Policy Research Unit in Maternal Health and Care, University of Oxford. I spent 100% of my time on academic activities.
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GP Fact sheet

GP INFORMATION SHEET
UK COLLABORATIVE TRIAL OF OVARIAN CANCER SCREENING

(UKCTOCS)

Funding bodies MRC, NHS R&D, Cancer Research UK, Research into Ovarian Cancer (ROC), Gynaecology Cancer Research Fund (GCRF)
Design/Intervention

Randomised controlled trial with three arms:

  1. A control group (no screening).
  2. A multimodal group (annual screening with serum CA 125 as the primary test and CA125 and ultrasound as the secondary test).
  3. An ultrasound group (annual screening with ultrasound as the primary test and repeat ultrasound in 6-8 weeks as the secondary test).
Objectives/aims:

Objective 1

  • To establish the impact of screening on ovarian cancer mortality

Objective 2

  • To determine the physical morbidity of ovarian cancer screening.
  • To determine the resource implications of screening.
  • To record the psychological consequences of screening.
  • To assess the feasibility of population screening for ovarian cancer as reflected by uptake of invitations and compliance rates with annual screening.
  • To compare the performance of two screening strategies for ovarian cancer

Objective 3

  • To establish a serum bank for future assessment of novel tumour markers.
Endpoints/primary outcomes:
 		Ovarian cancer mortality at 7 years after randomisation.
Inclusion/Exclusion criteria:

Inclusion criteria

  1. Age 50-74 years:
  2. Postmenopausal: Either (a) >12 months amenorrhoea following a natural menopause or hysterectomy, or (b) >12 months of hormone replacement therapy (HRT) commenced for menopausal symptoms.

Exclusion criteria

  1. History of bilateral oophorectomy.
  2. Currently active non-ovarian malignancy. Women who have a past history of malignancy will only be eligible if (a) they have no documented persistent or recurrent disease and (b) have not received treatment for >12 months.
  3. Women who have had an ovarian malignancy in the past.
  4. Women at high risk of ovarian cancer due to familial predisposition as defined by the eligibility criteria for the UKCCCR Familial Ovarian Cancer Screening Study.
  5. Women participating in other ovarian cancer screening trials
Recruitment
 		Women aged 50-74 will be sent invitations to participate from Heath Authority age/sex registers over a 3 year period. Note that women cannot volunteer or be referred to participate in this trial
Planned sample size:
 		200,000 postmenopausal women, 100,000 randomised to the control arm, 50,000 randomised to multimodal screening, 50,000 randomised to ultrasound screening.
Follow up:
  1. Postal questionnaire: All study participants will be asked to complete a health questionnaire midway through the trial and at the end of their participation in the trial (i.e. at 3.5 and 7 years after randomisation).
  2. National Health Service Central Register: All study participants will be flagged using their NHS number through either the National Health Service Central Register for England and Wales or the Cancer Registry of Scotland depending upon their place of residence.
Trial duration: January 2001 - December 2010
Contact Details: UKCTOCS Co-ordinating Centre
Gynaecological Oncology Unit,
St. Bartholomew’s & The Royal London School of Medicine and Dentistry
Charterhouse Square
London EC1M 6GR
Tel: 020 7882 5940, Fax: 020 7882 5961

Page last modified on 06 oct 09 12:48 by Vijay Devineni