title: Evaluating the risk of ovarian cancer before surgery using the ADNEX model to differentiate between benign, borderline, early and advanced stage invasive, and secondary metastatic tumours: prospective multicentre diagnostic study.
abstract: OBJECTIVE
  To develop a risk prediction model to preoperatively discriminate between benign, borderline, stage I invasive, stage II-IV invasive, and secondary metastatic ovarian tumours.
  
  
  METHODS
  Observational diagnostic study using prospectively collected clinical and ultrasound data.
  
  
  METHODS
  24 ultrasound centres in 10 countries.
  
  
  METHODS
  Women with an ovarian (including para-ovarian and tubal) mass and who underwent a standardised ultrasound examination before surgery. The model was developed on 3506 patients recruited between 1999 and 2007, temporally validated on 2403 patients recruited between 2009 and 2012, and then updated on all 5909 patients.
  
  
  METHODS
  Histological classification and surgical staging of the mass.
  
  
  RESULTS
  The Assessment of Different NEoplasias in the adneXa (ADNEX) model contains three clinical and six ultrasound predictors: age, serum CA-125 level, type of centre (oncology centres v other hospitals), maximum diameter of lesion, proportion of solid tissue, more than 10 cyst locules, number of papillary projections, acoustic shadows, and ascites. The area under the receiver operating characteristic curve (AUC) for the classic discrimination between benign and malignant tumours was 0.94 (0.93 to 0.95) on temporal validation. The AUC was 0.85 for benign versus borderline, 0.92 for benign versus stage I cancer, 0.99 for benign versus stage II-IV cancer, and 0.95 for benign versus secondary metastatic. AUCs between malignant subtypes varied between 0.71 and 0.95, with an AUC of 0.75 for borderline versus stage I cancer and 0.82 for stage II-IV versus secondary metastatic. Calibration curves showed that the estimated risks were accurate.
  
  
  CONCLUSIONS
  The ADNEX model discriminates well between benign and malignant tumours and offers fair to excellent discrimination between four types of ovarian malignancy. The use of ADNEX has the potential to improve triage and management decisions and so reduce morbidity and mortality associated with adnexal pathology.
authors.affiliation: Department of Development and Regeneration, KU Leuven, Herestraat 49 box 7003, 3000 Leuven, Belgium ben.vancalster@med.kuleuven.be.
authors.forename: Ben
authors.initials: B
authors.lastname: Van Calster
authors.affiliation: Department of Electrical Engineering, KU Leuven, Leuven, Belgium iMinds Medical Information Technologies, KU Leuven, Leuven, Belgium.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Van Hoorde
authors.affiliation: Department of Obstetrics and Gynaecology, Skåne University Hospital Malmö, Lund University, Malmö, Sweden.
authors.forename: Lil
authors.initials: L
authors.lastname: Valentin
authors.affiliation: Department of Oncology, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Antonia C
authors.initials: AC
authors.lastname: Testa
authors.affiliation: Gynaecological Oncology Center, Department of Obstetrics and Gynaecology, Charles University, Prague, Czech Republic.
authors.forename: Daniela
authors.initials: D
authors.lastname: Fischerova
authors.affiliation: Department of Obstetrics and Gynaecology, Ziekenhuis Oost Limburg, Genk, Belgium.
authors.forename: Caroline
authors.initials: C
authors.lastname: Van Holsbeke
authors.affiliation: Gynaecology and Reproductive Medicine Unit, S Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Savelli
authors.affiliation: Preventive Gynaecology Unit, Division of Gynaecology, European Institute of Oncology, Milan, Italy.
authors.forename: Dorella
authors.initials: D
authors.lastname: Franchi
authors.affiliation: Department of Obstetrics and Gynaecology, Karolinska University Hospital, Stockholm, Sweden.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Epstein
authors.affiliation: Department of Development and Regeneration, KU Leuven, Herestraat 49 box 7003, 3000 Leuven, Belgium Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium.
authors.forename: Jeroen
authors.initials: J
authors.lastname: Kaijser
authors.affiliation: Department of Electrical Engineering, KU Leuven, Leuven, Belgium iMinds Medical Information Technologies, KU Leuven, Leuven, Belgium.
authors.forename: Vanya
authors.initials: V
authors.lastname: Van Belle
authors.affiliation: 1st Department of Gynaecological Oncology and Gynaecology, Medical University in Lublin, Lublin, Poland.
authors.forename: Artur
authors.initials: A
authors.lastname: Czekierdowski
authors.affiliation: Department of Obstetrics and Gynaecology, Azienda Ospedaliero Universitaria di Cagliari, Cagliari, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Guerriero
authors.affiliation: Clinic of Obstetrics and Gynaecology, University of Milan-Bicocca, San Gerardo Hospital, Monza, Italy.
authors.forename: Robert
authors.initials: R
authors.lastname: Fruscio
authors.affiliation: Department of Woman, Mother and Neonate, Buzzi Children's Hospital, Biological and Clinical School of Medicine, University of Milan, Milan, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Lanzani
authors.affiliation: Department of Gynaecologic Oncology, Istituto Nazionale Tumori, Naples, Italy.
authors.forename: Felice
authors.initials: F
authors.lastname: Scala
authors.affiliation: Department of Development and Regeneration, KU Leuven, Herestraat 49 box 7003, 3000 Leuven, Belgium Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium Queen Charlotte's and Chelsea Hospital, Imperial College, London, UK.
authors.forename: Tom
authors.initials: T
authors.lastname: Bourne
authors.affiliation: Department of Development and Regeneration, KU Leuven, Herestraat 49 box 7003, 3000 Leuven, Belgium Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium.
authors.forename: Dirk
authors.initials: D
authors.lastname: Timmerman
mesh_terms: D000291:Adnexal Diseases / Q000000981:diagnostic imaging* / Q000473:pathology; D000328:Adult; D005260:Female; D006801:Humans; D015233:Models, Statistical; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology; D011237:Predictive Value of Tests; D011446:Prospective Studies; D018570:Risk Assessment / Q000379:methods*; D014463:Ultrasonography