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. Issue 8 (9th August 2016)

• Record Type: Journal Article
• Authors: 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
• Other Names: author non-byline.; Nagar Hans author non-byline.; Abedin Parveen author non-byline.; Jermy Karen author non-byline.; Ghazal Fateh author non-byline.; Duncan Tim author non-byline.; Hughes Tracey author non-byline.; Willett Mark author non-byline.; Abdi Shahram author non-byline.; Keating Patrick author non-byline.; Kaushik Sonali author non-byline.; Roberts Mark author non-byline.; Sengupta Partha author non-byline.; Sharma Aarti author non-byline.; Balogun Moji author non-byline.; Khan Humaira author non-byline.; Rai Harinder author non-byline.; Ames Victoria author non-byline.; Johnson Susanne author non-byline.; Nagaraju Eswarappa author non-byline.; Butcher Tracy author non-byline.; Vitta Lavanya author non-byline.; McGrady Yasmin author non-byline.; Kent Robert author non-byline.; Sinha Anju author non-byline.
• Is Part Of: BMJ open. Volume 6:Issue 8(2016)
• Publication Date: 2016-08-09
• Subjects: GYNAECOLOGY; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2015-010333
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: 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.