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ISRCTN
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ISRCTN22488978
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DOI
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10.1186/ISRCTN22488978
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ClinicalTrials.gov identifier
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NCT00058032
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EudraCT number
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Public title
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UK Collaborative Trial of Ovarian Cancer Screening
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Scientific title
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Acronym
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UKCTOCS
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Serial number at source
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G9901012
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Study hypothesis
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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
3. To determine the resource implications of screening and the interventions which result from screening
4. To record the psychological consequences of screening in the subgroups of true negative, true positive, false negative and false positive screening results
5. To assess the feasibility of population screening for ovarian cancer as reflected by uptake of invitations and compliance rates with annual screening
6. To compare the performance of two screening strategies for ovarian cancer
7. To establish a serum bank for future assessment of novel tumour markers
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Lay summary
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http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-at-screening-the-general-population-for-ovarian-cancer
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Ovarian cancer
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Participants - inclusion criteria
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1. Aged 50 - 74 years
2. Postmenopausal: either
2.1. Greater than 12 months amenorrhoea following a natural menopause or hysterectomy, or
2.2. Greater than 12 months of hormone replacement therapy (HRT) commenced for menopausal symptoms
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Participants - exclusion criteria
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1. History of bilateral oophorectomy
2. Currently active non-ovarian malignancy. Women who have a past history of malignancy will only be eligible if:
2.1. They have no documented persistent or recurrent disease, and
2.2. They 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
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Anticipated start date
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04/11/2000
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Anticipated end date
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03/11/2012
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Status of trial
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Completed |
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Patient information material
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Patient information can be found at: http://www.ukctocs.org.uk/stats.htm#two
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Target number of participants
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200,000
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Interventions
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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)
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Primary outcome measure(s)
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Ovarian cancer mortality at 7 years after randomisation.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (UK)
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Trial website
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http://www.ukctocs.org.uk/
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Publications
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1. 2009 results of the prevalence screen in http://www.ncbi.nlm.nih.gov/pubmed/19282241
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21147030
3. 2012 cohort study in http://www.ncbi.nlm.nih.gov/pubmed/21762355
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Contact name
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Prof
IJ
Jacobs
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Address
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Gynaecology Oncology Unit
University College London
Institute for Women's Health, EGA Hospital
Huntley Street
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City/town
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London
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Zip/Postcode
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WC1E 6DH
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Country
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United Kingdom
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Email
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Sponsor
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University College London (UK)
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Address
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Gower Street
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City/town
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London
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Zip/Postcode
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WC1E 6BT
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Country
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United Kingdom
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Tel
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+44 (0)20 7679 2000
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Email
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Sponsor website:
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http://www.ucl.ac.uk/
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Date applied
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06/04/2000
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Last edited
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07/02/2012
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Date ISRCTN assigned
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06/04/2000
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