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UK Collaborative Trial of Ovarian Cancer Screening
DOI 10.1186/ISRCTN22488978
ClinicalTrials.gov identifier NCT00058032
EudraCT number
Public title UK Collaborative Trial of Ovarian Cancer Screening
Scientific title
Serial number at source G9901012
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
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
Lay summary http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-at-screening-the-general-population-for-ovarian-cancer
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Ovarian cancer
Participants - inclusion criteria 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
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:
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
Anticipated start date 04/11/2000
Anticipated end date 03/11/2012
Status of trial Completed
Patient information material Patient information can be found at: http://www.ukctocs.org.uk/stats.htm#two
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
Sources of funding Medical Research Council (UK)
Trial website http://www.ukctocs.org.uk/
Publications 2009 results of the prevalence screen in: http://www.ncbi.nlm.nih.gov/pubmed/19282241
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21147030
2012 cohort study in: http://www.ncbi.nlm.nih.gov/pubmed/21762355
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24122770
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24589827
2014 psychological morbidity results in: http://www.ncbi.nlm.nih.gov/pubmed/24865441
2014 cohort study results in: http://www.ncbi.nlm.nih.gov/pubmed/25252818
Contact name Prof  IJ  Jacobs
  Address Gynaecology Oncology Unit
University College London
Institute for Women's Health, EGA Hospital
Huntley Street
  City/town London
  Zip/Postcode WC1E 6DH
  Country United Kingdom
Sponsor University College London (UK)
  Address Gower Street
  City/town London
  Zip/Postcode WC1E 6BT
  Country United Kingdom
  Tel +44 (0)20 7679 2000
  Sponsor website: http://www.ucl.ac.uk/
Date applied 06/04/2000
Last edited 26/09/2014
Date ISRCTN assigned 06/04/2000
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