Tubo-ovarian cancer Cancer Ovarian cancer
Conditions
Interventions
Current intervention as of 24/08/2020:
Three groups:
1. A control group (no screening)
2. A multimodal group (annual screening with serum CA125 interpreted using the Risk of Ovarian Cancer Algorithm (
Sponsors
University College London (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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 UK Familial Ovarian Cancer Screening Study (UKFOCSS) 5. Women participating in other ovarian screening trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 24/08/2020: UKCTOCS: Ovarian cancer mortality at 7 years after randomisation. Death due to ovarian cancer, defined by WHO 2003 criteria, as determined by independent outcomes committee review of patient notes of all women identified through data linkage and postal follow-up to have a ‘possible ovarian cancer’ (pre-specified list of International Classification of Disease codes) up to 31st December 2014. Long term impact of screening on ovarian cancer mortality in UKCTOCS (LTFU UKCTOCS): Death due to ovarian cancer, defined by WHO 2014 criteria as determined by independent outcomes committee review of patient notes of all women identified through data linkage to have a ‘possible ovarian cancer’ (pre-specified list of International Classification of Disease codes) up to 30th June 2020. Previous primary outcome measure as of 04/01/2017: Randomised controlled trial: Ovarian cancer mortality at 7 years after randomisation. Death due to ovarian cancer, defined by WHO 2003 criteria, as determined by independent outcomes committee review of patient notes of all women identified through data linkage and postal follow-up to have a ‘possible ovarian cancer’ (pre-specified list of International Classification of Disease codes) till 31st December 2014. Observational longitudinal follow up study: Death due to ovarian cancer, defined by WHO 2014 criteria as determined by independent outcomes committee review of patient notes of all women identified through data linkage to have a ‘possible ovarian cancer’ (pre-specified list of International Classification of Disease codes) till 31st December 2018. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 24/08/2020: UKCTOCS: 1. Performance characteristics: Sensitivity, specificity, positive predictive values of the two screening strategies (multimodal and ultrasound) for detection of ovarian cancer diagnosed within 1 year of last screen. Ovarian cancer diagnosis is based on outcomes review of medical notes of all women who developed ovarian cancer during the trial. 2. Surgical complications in women who underwent false positive surgery and were found to have benign or normal adnexae. This is assessed through central medical note review and assigned by designated trial gynaecological oncologist. 3. Cost-effectivenesss of the multimodal (MMS) and ultrasound screening (USS) strategies separately comparing them to a no-screening arm: 3.1. Incremental cost-effectiveness analysis over the 14-year period of the trial (censorship 31st Dec 2014) 3.2. Incremental cost-effectiveness analysis for the cumulative mortality estimated over a 25-year period by extrapolating beyond the 14 years of the trial 4. Compliance with annual screening: The proportion of women who attended all tests that formed part of an annual screening episode of the total who were eligible for that annual screening episode. Psychological morbidity related to screening - assessed in a separate MRC funded study, UKCTOCS Psychosocial study, PI Prof Dame Lesley Fallowfield. LTFU UKCTOCS: Cost-effectiveness of ovarian cancer screening: This will be assessed using individual patient datafrom English (Hospital Episodes Statistics), Welsh (Patient Episode Database for Wales) and Northern Ireland hospital administrative databases. The data will be augmented with resource data collected on individual diagnostic tests and treatment through medical record review. All unit costs will be based on NHS Reference Costs with additional costs as reported by the relevantPersonal Social Services Research Unit Cost exercise. Previous secondary outcome measures as of 04/01/2017: Random | — |
Countries
England, Northern Ireland, United Kingdom, Wales
Outcome results
None listed