Performance Characteristics of the Ultrasound Strategy during Incidence Screening in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS)

Randomised controlled trials of ovarian cancer (OC) screening have not yet demonstrated an impact on disease mortality. Meanwhile, the screening data from clinical trials represents a rich resource to understand the performance of modalities used. We report here on incidence screening in the ultraso...

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Main Authors: Jatinderpal Kalsi, Aleksandra Gentry-Maharaj, Andy Ryan, Naveena Singh, Matthew Burnell, Susan Massingham, Sophia Apostolidou, Aarti Sharma, Karin Williamson, Mourad Seif, Tim Mould, Robert Woolas, Stephen Dobbs, Simon Leeson, Lesley Fallowfield, Steven J. Skates, Mahesh Parmar, Stuart Campbell, Ian Jacobs, Alistair McGuire, Usha Menon
Format: Article
Language:English
Published: MDPI AG 2021-02-01
Series:Cancers
Subjects:
Online Access:https://www.mdpi.com/2072-6694/13/4/858
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author Jatinderpal Kalsi
Aleksandra Gentry-Maharaj
Andy Ryan
Naveena Singh
Matthew Burnell
Susan Massingham
Sophia Apostolidou
Aarti Sharma
Karin Williamson
Mourad Seif
Tim Mould
Robert Woolas
Stephen Dobbs
Simon Leeson
Lesley Fallowfield
Steven J. Skates
Mahesh Parmar
Stuart Campbell
Ian Jacobs
Alistair McGuire
Usha Menon
author_facet Jatinderpal Kalsi
Aleksandra Gentry-Maharaj
Andy Ryan
Naveena Singh
Matthew Burnell
Susan Massingham
Sophia Apostolidou
Aarti Sharma
Karin Williamson
Mourad Seif
Tim Mould
Robert Woolas
Stephen Dobbs
Simon Leeson
Lesley Fallowfield
Steven J. Skates
Mahesh Parmar
Stuart Campbell
Ian Jacobs
Alistair McGuire
Usha Menon
author_sort Jatinderpal Kalsi
collection DOAJ
description Randomised controlled trials of ovarian cancer (OC) screening have not yet demonstrated an impact on disease mortality. Meanwhile, the screening data from clinical trials represents a rich resource to understand the performance of modalities used. We report here on incidence screening in the ultrasound arm of UKCTOCS. 44,799 of the 50,639 women who were randomised to annual screening with transvaginal ultrasound attended annual incidence screening between 28 April 2002 and 31 December 2011. Transvaginal ultrasound was used both as the first and the second line test. Participants were followed up through electronic health record linkage and postal questionnaires. Out of 280,534 annual incidence screens, 960 women underwent screen-positive surgery. 113 had ovarian/tubal cancer (80 invasive epithelial). Of the screen-detected invasive epithelial cancers, 37.5% (95% CI: 26.9–49.0) were Stage I/II. An additional 52 (50 invasive epithelial) were diagnosed within one year of their last screen. Of the 50 interval epithelial cancers, 6.0% (95% CI: 1.3–16.5) were Stage I/II. For detection of all ovarian/tubal cancers diagnosed within one year of screen, the sensitivity, specificity, and positive predictive values were 68.5% (95% CI: 60.8–75.5), 99.7% (95% CI: 99.7–99.7), and 11.8% (95% CI: 9.8–14) respectively. When the analysis was restricted to invasive epithelial cancers, sensitivity, specificity and positive predictive values were 61.5% (95% CI: 52.6–69.9); 99.7% (95% CI: 99.7–99.7) and 8.3% (95% CI: 6.7–10.3), with 12 surgeries per screen positive. The low sensitivity coupled with the advanced stage of interval cancers suggests that ultrasound scanning as the first line test might not be suitable for population screening for ovarian cancer. Trial registration: ISRCTN22488978. Registered on 6 April 2000.
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spelling doaj.art-1718b9740cb147688cda9e70d83d01522023-12-11T17:29:04ZengMDPI AGCancers2072-66942021-02-0113485810.3390/cancers13040858Performance Characteristics of the Ultrasound Strategy during Incidence Screening in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS)Jatinderpal Kalsi0Aleksandra Gentry-Maharaj1Andy Ryan2Naveena Singh3Matthew Burnell4Susan Massingham5Sophia Apostolidou6Aarti Sharma7Karin Williamson8Mourad Seif9Tim Mould10Robert Woolas11Stephen Dobbs12Simon Leeson13Lesley Fallowfield14Steven J. Skates15Mahesh Parmar16Stuart Campbell17Ian Jacobs18Alistair McGuire19Usha Menon20Department of Women’s Cancer, Institute for Women’s Health, University College London, London WC1E 6HU, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, London WC1V 6LJ, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, London WC1V 6LJ, UKDepartment of Pathology, Barts and the London, London E1 2ES, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, London WC1V 6LJ, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, London WC1V 6LJ, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, London WC1V 6LJ, UKDepartment of Obstetrics and Gynaecology, University Hospital of Wales, Cardiff CF14 4XW, UKDepartment of Gynaecological Oncology, Nottingham City Hospital, Nottingham NG5 1PB, UKDivision of Gynaecology and of Cancer Services, St. Mary’s Hospital and University of Manchester, Manchester M13 9WL, UKDepartment of Gynaecological Oncology, University College Hospital, London NW1 2BU, UKDepartment of Gynaecological Oncology, Queen Alexandra Hospital, Portsmouth PO6 3LY, UKDepartment of Gynaecological Oncology, Belfast City Hospital, Belfast BT9 7AB, UKDepartment of Obstetrics and Gynaecology, Ysbyty Gwynedd, Bangor, Gwynedd LL57 2PW, UKCancer Research UK Sussex Psychosocial Oncology Group at Brighton & Sussex Medical School, University of Sussex, Falmer BN1 9PX, UKMassachusetts General Hospital, Harvard Medical School, Boston, MA 02115, USAMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, London WC1V 6LJ, UKCreate Fertility Clinic, London EC2V 6ET, UKDepartment of Women’s Cancer, Institute for Women’s Health, University College London, London WC1E 6HU, UKLondon School of Economics and Political Science, London WC2A 2AE, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, London WC1V 6LJ, UKRandomised controlled trials of ovarian cancer (OC) screening have not yet demonstrated an impact on disease mortality. Meanwhile, the screening data from clinical trials represents a rich resource to understand the performance of modalities used. We report here on incidence screening in the ultrasound arm of UKCTOCS. 44,799 of the 50,639 women who were randomised to annual screening with transvaginal ultrasound attended annual incidence screening between 28 April 2002 and 31 December 2011. Transvaginal ultrasound was used both as the first and the second line test. Participants were followed up through electronic health record linkage and postal questionnaires. Out of 280,534 annual incidence screens, 960 women underwent screen-positive surgery. 113 had ovarian/tubal cancer (80 invasive epithelial). Of the screen-detected invasive epithelial cancers, 37.5% (95% CI: 26.9–49.0) were Stage I/II. An additional 52 (50 invasive epithelial) were diagnosed within one year of their last screen. Of the 50 interval epithelial cancers, 6.0% (95% CI: 1.3–16.5) were Stage I/II. For detection of all ovarian/tubal cancers diagnosed within one year of screen, the sensitivity, specificity, and positive predictive values were 68.5% (95% CI: 60.8–75.5), 99.7% (95% CI: 99.7–99.7), and 11.8% (95% CI: 9.8–14) respectively. When the analysis was restricted to invasive epithelial cancers, sensitivity, specificity and positive predictive values were 61.5% (95% CI: 52.6–69.9); 99.7% (95% CI: 99.7–99.7) and 8.3% (95% CI: 6.7–10.3), with 12 surgeries per screen positive. The low sensitivity coupled with the advanced stage of interval cancers suggests that ultrasound scanning as the first line test might not be suitable for population screening for ovarian cancer. Trial registration: ISRCTN22488978. Registered on 6 April 2000.https://www.mdpi.com/2072-6694/13/4/858ovarian cancerscreeningultrasoundTVSearly detectiontrial
spellingShingle Jatinderpal Kalsi
Aleksandra Gentry-Maharaj
Andy Ryan
Naveena Singh
Matthew Burnell
Susan Massingham
Sophia Apostolidou
Aarti Sharma
Karin Williamson
Mourad Seif
Tim Mould
Robert Woolas
Stephen Dobbs
Simon Leeson
Lesley Fallowfield
Steven J. Skates
Mahesh Parmar
Stuart Campbell
Ian Jacobs
Alistair McGuire
Usha Menon
Performance Characteristics of the Ultrasound Strategy during Incidence Screening in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS)
Cancers
ovarian cancer
screening
ultrasound
TVS
early detection
trial
title Performance Characteristics of the Ultrasound Strategy during Incidence Screening in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS)
title_full Performance Characteristics of the Ultrasound Strategy during Incidence Screening in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS)
title_fullStr Performance Characteristics of the Ultrasound Strategy during Incidence Screening in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS)
title_full_unstemmed Performance Characteristics of the Ultrasound Strategy during Incidence Screening in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS)
title_short Performance Characteristics of the Ultrasound Strategy during Incidence Screening in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS)
title_sort performance characteristics of the ultrasound strategy during incidence screening in the uk collaborative trial of ovarian cancer screening ukctocs
topic ovarian cancer
screening
ultrasound
TVS
early detection
trial
url https://www.mdpi.com/2072-6694/13/4/858
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