| Source of record | UK Trials |
| ISRCTN | ISRCTN22488978 |
| Date ISRCTN assigned | 06/04/2000 |
| Local reference number(s) | G9901012 |
| Public title | UK Collaborative Trial of Ovarian Cancer Screening |
| Scientific title |
|
| Acronym | UKCTOCS |
| Disease/condition/study domain | Ovarian cancer |
| Study hypothesis | 1. To establish the impact of preclinical detection of ovarian cancer by screening on ovarian cancer mortality
2. To determine the physical morbidity of ovarian cancer screening. To determine the resource implications of screening and the interventions which result from screening. To record the psychological consequences of screening in the subgroups of true negative, true positive, false negative and false positive screening results. 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
3. To establish a serum bank for future assessment of novel tumour markers |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Age 50-74 years
2. Postmenopausal: Either (a) greater than 12 months amenorrhoea following a natural menopause or hysterectomy, or (b) greater than 12 months of hormone replacement therapy (HRT) commenced for menopausal symptoms |
| Participants - 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 more than 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 screening trials |
| Patient information material | Patient information can be found at: http://www.ukctocs.org.uk/stats.htm#two |
| Anticipated start date | 04/11/2000 |
| Anticipated end date | 03/11/2012 |
| Status of trial | Ongoing |
| Target number of participants | 200,000 |
| Interventions | Three groups:
1. A control group (no screening)
2. A multimodal group (annual screening with serum CA125 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) |
| Primary outcome measure(s) | Ovarian cancer mortality at 7 years after randomisation. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Trial website | http://www.ukctocs.org.uk/ |
| Sources of funding | Medical Research Council |
| Sponsor name | University College London (UK) |
| Sponsor details | Gower Street
London
United Kingdom
WC1E 6BT |
| Sponsor telephone | +44 (0)20 7679 2000 |
| Sponsor website | http://www.ucl.ac.uk/ |
| Contact name | Prof IJ Jacobs |
| Contact details | Gynaecology Oncology Unit
University College London
Institute for Women's Health, EGA Hospital
Huntley Street
London
United Kingdom
WC1E 6DH |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN22488978 |
| Date last extracted from ISRCTN register | 17/04/2008 |
