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| ID | Type | Description | Link |
|---|---|---|---|
| UKCTOCS | |||
| EU-20249 |
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| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
| The Eve Appeal | UNKNOWN |
| Medical Research Council | OTHER_GOV |
| Cancer Research UK |
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RATIONALE: Screening tests may help doctors detect ovarian cancer early when the survival is much more encouraging. It is not yet known whether a CA125-based or ultrasound strategy is more effective in detecting ovarian cancer early thereby impacting on the mortality from the disease in postmenopausal women from the general population.
PURPOSE: Randomized clinical trial to assess the impact of screening using a multimodal strategy using CA125 interpreted by the Risk of Ovarian Cancer Algorithm (ROCA) followed by transvaginal ultrasound as a second line test versus transvaginal ultrasound on mortality from the disease in postmenopausal women from the general population.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Participants are randomized to 1 of 3 screening arms.
Participants in all arms complete a health questionnaire at 3-5 years after study entry and in 2014.
PROJECTED ACCRUAL: A total of 200,000 participants (100,000 for arm I and 50,000 each for arms II and III) will be accrued for this study within 5 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| screening questionnaire administration | Other | |||
| annual screening | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| UKCTOCS (2001-2014): Death due to ovarian cancer (WHO 2003) determined by independent outcomes committee review of patient notes for all women identified to have a 'possible ovarian cancer' (pre-specified ICD-10 codes) till 31st December 2014. | ||
| Long term impact of screening on ovarian cancer mortality in the UKCTOCS (LTFU UKCTOCS) (2015-2021): Death due to ovarian cancer (WHO 2014) determined by independent outcomes committee review till 30 June 2020. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance characteristics: Sensitivity, specificity, positive predictive values of the two screening strategies (multimodal and ultrasound) for detection of ovarian cancer diagnosed within one 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. |
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DISEASE CHARACTERISTICS:
Postmenopausal, as defined by meeting 1 of the following criteria:
No prior ovarian malignancy
No prior bilateral oophorectomy
Not at high risk for ovarian cancer due to familial predisposition as defined by the UKCCCR Familial Ovarian Cancer Screening Study
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
No active non-ovarian malignancy
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Usha Menon, MBBS, MRCOG | University College, London | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21147030 | Result | Jacobs I, Gentry-Maharaj A, Burnell M, Manchanda R, Singh N, Sharma A, Ryan A, Seif MW, Amso NN, Turner G, Brunell C, Fletcher G, Rangar R, Ford K, Godfrey K, Lopes A, Oram D, Herod J, Williamson K, Scott I, Jenkins H, Mould T, Woolas R, Murdoch J, Dobbs S, Leeson S, Cruickshank D, Skates SJ, Fallowfield L, Parmar M, Campbell S, Menon U. Sensitivity of transvaginal ultrasound screening for endometrial cancer in postmenopausal women: a case-control study within the UKCTOCS cohort. Lancet Oncol. 2011 Jan;12(1):38-48. doi: 10.1016/S1470-2045(10)70268-0. Epub 2010 Dec 10. | |
| 19282241 |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| OTHER |
202,638 participants randomised to: Multimodal Group: 50640 Ultrasound Group: 50639 Control Group: 101359
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| 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. |
| Cost-effectivenesss of the multimodal (MMS) and ultrasound screening (USS) strategies separately comparing them to a no-screening arm. | Cost-effectivenesss of the multimodal (MMS) and ultrasound screening (USS) strategies separately comparing them to a no-screening arm: (a) Incremental cost-effectiveness analysis over the 14 year period of the trial (censorship 31st Dec 2014); (b) Incremental cost-effectiveness analysis for the cumulative mortality estimated over a 25-year period by extrapolating beyond the 14 years of the trial |
| 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. |
| Result |
| Menon U, Gentry-Maharaj A, Hallett R, Ryan A, Burnell M, Sharma A, Lewis S, Davies S, Philpott S, Lopes A, Godfrey K, Oram D, Herod J, Williamson K, Seif MW, Scott I, Mould T, Woolas R, Murdoch J, Dobbs S, Amso NN, Leeson S, Cruickshank D, McGuire A, Campbell S, Fallowfield L, Singh N, Dawnay A, Skates SJ, Parmar M, Jacobs I. Sensitivity and specificity of multimodal and ultrasound screening for ovarian cancer, and stage distribution of detected cancers: results of the prevalence screen of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Lancet Oncol. 2009 Apr;10(4):327-40. doi: 10.1016/S1470-2045(09)70026-9. Epub 2009 Mar 11. |
| 26707054 | Result | Jacobs IJ, Menon U, Ryan A, Gentry-Maharaj A, Burnell M, Kalsi JK, Amso NN, Apostolidou S, Benjamin E, Cruickshank D, Crump DN, Davies SK, Dawnay A, Dobbs S, Fletcher G, Ford J, Godfrey K, Gunu R, Habib M, Hallett R, Herod J, Jenkins H, Karpinskyj C, Leeson S, Lewis SJ, Liston WR, Lopes A, Mould T, Murdoch J, Oram D, Rabideau DJ, Reynolds K, Scott I, Seif MW, Sharma A, Singh N, Taylor J, Warburton F, Widschwendter M, Williamson K, Woolas R, Fallowfield L, McGuire AJ, Campbell S, Parmar M, Skates SJ. Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial. Lancet. 2016 Mar 5;387(10022):945-956. doi: 10.1016/S0140-6736(15)01224-6. Epub 2015 Dec 17. |
| 25964255 | Result | Menon U, Ryan A, Kalsi J, Gentry-Maharaj A, Dawnay A, Habib M, Apostolidou S, Singh N, Benjamin E, Burnell M, Davies S, Sharma A, Gunu R, Godfrey K, Lopes A, Oram D, Herod J, Williamson K, Seif MW, Jenkins H, Mould T, Woolas R, Murdoch JB, Dobbs S, Amso NN, Leeson S, Cruickshank D, Scott I, Fallowfield L, Widschwendter M, Reynolds K, McGuire A, Campbell S, Parmar M, Skates SJ, Jacobs I. Risk Algorithm Using Serial Biomarker Measurements Doubles the Number of Screen-Detected Cancers Compared With a Single-Threshold Rule in the United Kingdom Collaborative Trial of Ovarian Cancer Screening. J Clin Oncol. 2015 Jun 20;33(18):2062-71. doi: 10.1200/JCO.2014.59.4945. Epub 2015 May 11. |
| 19008269 | Result | Menon U, Gentry-Maharaj A, Ryan A, Sharma A, Burnell M, Hallett R, Lewis S, Lopez A, Godfrey K, Oram D, Herod J, Williamson K, Seif M, Scott I, Mould T, Woolas R, Murdoch J, Dobbs S, Amso N, Leeson S, Cruickshank D, McGuire A, Campbell S, Fallowfield L, Skates S, Parmar M, Jacobs I. Recruitment to multicentre trials--lessons from UKCTOCS: descriptive study. BMJ. 2008 Nov 13;337:a2079. doi: 10.1136/bmj.a2079. |
| 37980767 | Derived | Dilley J, Gentry-Maharaj A, Ryan A, Burnell M, Manchanda R, Kalsi J, Singh N, Woolas R, Sharma A, Williamson K, Mould T, Fallowfield L, Campbell S, Skates SJ, McGuire A, Parmar M, Jacobs I, Menon U. Ovarian cancer symptoms in pre-clinical invasive epithelial ovarian cancer - An exploratory analysis nested within the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Gynecol Oncol. 2023 Dec;179:123-130. doi: 10.1016/j.ygyno.2023.11.005. Epub 2023 Nov 18. |
| 37843101 | Derived | Menon U, Gentry-Maharaj A, Burnell M, Apostolidou S, Ryan A, Kalsi JK, Singh N, Fallowfield L, McGuire AJ, Campbell S, Skates SJ, Dawnay A, Parmar M, Jacobs IJ; UKCTOCS team. Insights from UKCTOCS for design, conduct and analyses of large randomised controlled trials. Health Technol Assess. 2023 Aug;29(10):1-48. doi: 10.3310/CLDC7214. |
| 37657461 | Derived | Menon U, Gentry-Maharaj A, Burnell M, Ryan A, Singh N, Manchanda R, Kalsi JK, Woolas R, Arora R, Casey L, Dawnay A, Sharma A, Williamson K, Apostolidou S, Fallowfield L, McGuire AJ, Campbell S, Skates SJ, Jacobs IJ, Parmar MKB. Tumour stage, treatment, and survival of women with high-grade serous tubo-ovarian cancer in UKCTOCS: an exploratory analysis of a randomised controlled trial. Lancet Oncol. 2023 Sep;24(9):1018-1028. doi: 10.1016/S1470-2045(23)00335-2. |
| 33991479 | Derived | Menon U, Gentry-Maharaj A, Burnell M, Singh N, Ryan A, Karpinskyj C, Carlino G, Taylor J, Massingham SK, Raikou M, Kalsi JK, Woolas R, Manchanda R, Arora R, Casey L, Dawnay A, Dobbs S, Leeson S, Mould T, Seif MW, Sharma A, Williamson K, Liu Y, Fallowfield L, McGuire AJ, Campbell S, Skates SJ, Jacobs IJ, Parmar M. Ovarian cancer population screening and mortality after long-term follow-up in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial. Lancet. 2021 Jun 5;397(10290):2182-2193. doi: 10.1016/S0140-6736(21)00731-5. Epub 2021 May 12. |
| 31388184 | Derived | Russell MR, Graham C, D'Amato A, Gentry-Maharaj A, Ryan A, Kalsi JK, Whetton AD, Menon U, Jacobs I, Graham RLJ. Diagnosis of epithelial ovarian cancer using a combined protein biomarker panel. Br J Cancer. 2019 Sep;121(6):483-489. doi: 10.1038/s41416-019-0544-0. Epub 2019 Aug 7. |
| 24879829 | Derived | Fraser L, Burnell M, Salter LC, Fourkala EO, Kalsi J, Ryan A, Gessler S, Gidron Y, Steptoe A, Menon U. Identifying hopelessness in population research: a validation study of two brief measures of hopelessness. BMJ Open. 2014 May 30;4(5):e005093. doi: 10.1136/bmjopen-2014-005093. |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |