Sudha Sundar
Refining Ovarian Cancer Test accuracy Scores (ROCkeTS): protocol for a prospective longitudinal test accuracy study to validate new risk scores in women with symptoms of suspected ovarian cancer
Sundar, Sudha; Rick, Caroline; Dowling, Francis; Au, Pui; Snell, Kym; Rai, Nirmala; Champaneria, Rita; Stobart, Hilary; Neal, Richard; Davenport, Clare; Mallett, Susan; Sutton, Andrew; Kehoe, Sean; Timmerman, Dirk; Bourne, Tom; Van Calster, Ben; Gentry-Maharaj, Aleksandra; Menon, Usha; Deeks, Jon
Authors
CAROLINE RICK Caroline.Rick@nottingham.ac.uk
Associate Professor
Francis Dowling
Pui Au
Kym Snell
Nirmala Rai
Rita Champaneria
Hilary Stobart
Richard Neal
Clare Davenport
Susan Mallett
Andrew Sutton
Sean Kehoe
Dirk Timmerman
Tom Bourne
Ben Van Calster
Aleksandra Gentry-Maharaj
Usha Menon
Jon Deeks
Abstract
© 2016 Published by the BMJ Publishing Group Limited. Ovarian cancer (OC) is associated with non-specific symptoms such as bloating, making accurate diagnosis challenging: only 1 in 3 women with OC presents through primary care referral. National Institute for Health and Care Excellence guidelines recommends sequential testing with CA125 and routine ultrasound in primary care. However, these diagnostic tests have limited sensitivity or specificity. Improving accurate triage in women with vague symptoms is likely to improve mortality by streamlining referral and care pathways. The Refining Ovarian Cancer Test Accuracy Scores (ROCkeTS; HTA 13/13/01) project will derive and validate new tests/risk prediction models that estimate the probability of having OC in women with symptoms. This protocol refers to the prospective study only (phase III). Methods and analysis ROCkeTS comprises four parallel phases. The full ROCkeTS protocol can be found at http://www.birmingham.ac.uk/ROCKETS. Phase III is a prospective test accuracy study. The study will recruit 2450 patients from 15 UK sites. Recruited patients complete symptom and anxiety questionnaires, donate a serum sample and undergo ultrasound scored as per International Ovarian Tumour Analysis (IOTA) criteria. Recruitment is at rapid access clinics, emergency departments and elective clinics. Models to be evaluated include those based on ultrasound derived by the IOTA group and novel models derived from analysis of existing data sets. Estimates of sensitivity, specificity, c-statistic (area under receiver operating curve), positive predictive value and negative predictive value of diagnostic tests are evaluated and a calibration plot for models will be presented. ROCkeTS has received ethical approval from the NHS West Midlands REC (14/WM/1241) and is registered on the controlled trials website (ISRCTN17160843) and the National Institute of Health Research Cancer and Reproductive Health portfolios.
Citation
Sundar, S., Rick, C., Dowling, F., Au, P., Snell, K., Rai, N., …Deeks, J. (2016). Refining Ovarian Cancer Test accuracy Scores (ROCkeTS): protocol for a prospective longitudinal test accuracy study to validate new risk scores in women with symptoms of suspected ovarian cancer. BMJ Open, 6(8), Article e010333. https://doi.org/10.1136/bmjopen-2015-010333
Journal Article Type | Article |
---|---|
Acceptance Date | Jul 11, 2016 |
Online Publication Date | Aug 9, 2016 |
Publication Date | 2016-08 |
Deposit Date | Jun 27, 2019 |
Publicly Available Date | Jul 24, 2019 |
Journal | BMJ Open |
Electronic ISSN | 2044-6055 |
Publisher | BMJ Publishing Group |
Peer Reviewed | Peer Reviewed |
Volume | 6 |
Issue | 8 |
Article Number | e010333 |
DOI | https://doi.org/10.1136/bmjopen-2015-010333 |
Public URL | https://nottingham-repository.worktribe.com/output/2235633 |
Publisher URL | https://bmjopen.bmj.com/content/6/8/e010333 |
Files
e010333.full
(1 Mb)
PDF
Publisher Licence URL
https://creativecommons.org/licenses/by/4.0/
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