title: 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.
abstract: 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).
  
  
  
  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.
authors: Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK Pan Birmingham Gynaecological Cancer Centre, City Hospital, Birmingham, UK.
authors: Sudha
authors: S
authors: Sundar
authors: Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
authors: Caroline
authors: C
authors: Rick
authors: Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
authors: Francis
authors: F
authors: Dowling
authors: Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
authors: Pui
authors: P
authors: Au
authors: Diagnostic Test Accuracy Group, University of Birmingham, Birmingham, UK.
authors: Kym
authors: 0000-0001-9373-6591
authors: K
authors: Snell
authors: Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK Diagnostic Test Accuracy Group, University of Birmingham, Birmingham, UK.
authors: Nirmala
authors: N
authors: Rai
authors: Diagnostic Test Accuracy Group, University of Birmingham, Birmingham, UK.
authors: Rita
authors: R
authors: Champaneria
authors: Patient Representative, Birmingham, UK.
authors: Hilary
authors: H
authors: Stobart
authors: Primary Care, Bangor University, North Wales, UK.
authors: Richard
authors: R
authors: Neal
authors: Diagnostic Test Accuracy Group, University of Birmingham, Birmingham, UK.
authors: Clare
authors: C
authors: Davenport
authors: Diagnostic Test Accuracy Group, University of Birmingham, Birmingham, UK.
authors: Susan
authors: S
authors: Mallett
authors: Health Economics, University of Birmingham, Birmingham, UK.
authors: Andrew
authors: A
authors: Sutton
authors: Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.
authors: Sean
authors: S
authors: Kehoe
authors: Department of Development and Regeneration, KU Leuven, Leuven, Belgium Department of Obstetrics and Gynaecology, KU Leuven, Leuven, Belgium.
authors: Dirk
authors: D
authors: Timmerman
authors: Department of Development and Regeneration, KU Leuven, Leuven, Belgium Department of Obstetrics and Gynaecology, KU Leuven, Leuven, Belgium Queen Charlotte's and Chelsea Hospital, Imperial College, London, UK.
authors: Tom
authors: T
authors: Bourne
authors: Department of Development and Regeneration, KU Leuven, Leuven, Belgium.
authors: Ben
authors: B
authors: Van Calster
authors: Department of Women's Cancer, Gynaecological Cancer Research Centre, Institute for Women's Health, UCL, London, UK.
authors: Aleksandra
authors: A
authors: Gentry-Maharaj
authors: Department of Women's Cancer, Gynaecological Cancer Research Centre, Institute for Women's Health, UCL, London, UK.
authors: Usha
authors: 0000-0003-3708-1732
authors: U
authors: Menon
authors: Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK Diagnostic Test Accuracy Group, University of Birmingham, Birmingham, UK.
authors: Jon
authors: J
authors: Deeks
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018394:CA-125 Antigen / Q000097:blood*; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000175:diagnosis*; D011446:Prospective Studies; D012107:Research Design; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index; D014463:Ultrasonography; D006113:United Kingdom; D055815:Young Adult
chemical_list: D018394:CA-125 Antigen
keywords: GYNAECOLOGY