title: Distinguishing benign from malignant pelvic mass utilizing an algorithm with HE4, menopausal status, and ultrasound findings.
abstract: OBJECTIVE
  The purpose of this study was to develop a risk prediction score for distinguishing benign ovarian mass from malignant tumors using CA-125, human epididymis protein 4 (HE4), ultrasound findings, and menopausal status. The risk prediction score was compared to the risk of malignancy index and risk of ovarian malignancy algorithm (ROMA).
  
  
  METHODS
  This was a prospective, multicenter (n=6) study with patients from six Asian countries. Patients had a pelvic mass upon imaging and were scheduled to undergo surgery. Serum CA-125 and HE4 were measured on preoperative samples, and ultrasound findings were recorded. Regression analysis was performed and a risk prediction model was developed based on the significant factors. A bootstrap technique was applied to assess the validity of the HE4 model.
  
  
  RESULTS
  A total of 414 women with a pelvic mass were enrolled in the study, of which 328 had documented ultrasound findings. The risk prediction model that contained HE4, menopausal status, and ultrasound findings exhibited the best performance compared to models with CA-125 alone, or a combination of CA-125 and HE4. This model classified 77.2% of women with ovarian cancer as medium or high risk, and 86% of women with benign disease as very-low, low, or medium-low risk. This model exhibited better sensitivity than ROMA, but ROMA exhibited better specificity. Both models performed better than CA-125 alone.
  
  
  CONCLUSIONS
  Combining ultrasound with HE4 can improve the sensitivity for detecting ovarian cancer compared to other algorithms.
authors.affiliation: Department of Obstetrics and Gynecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. sarikapan.wil@mahidol.ac.th.
authors.forename: Sarikapan
authors.initials: S
authors.lastname: Wilailak
authors.affiliation: Department of Obstetrics and Gynecology, University of Hong Kong, Hong Kong.
authors.forename: Karen K L
authors.initials: KK
authors.lastname: Chan
authors.affiliation: Department of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei, Taiwan.
authors.forename: Chi An
authors.initials: CA
authors.lastname: Chen
authors.affiliation: Department of Obstetrics and Gynecology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Joo Hyun
authors.initials: JH
authors.lastname: Nam
authors.affiliation: Department of Obstetrics and Gynecology, The Jikei University, Tokyo, Japan.
authors.forename: Kazunori
authors.initials: K
authors.lastname: Ochiai
authors.affiliation: Department of Laboratory Medicine, Changi General Hospital, Singapore.
authors.forename: Tar Choon
authors.initials: TC
authors.lastname: Aw
authors.affiliation: Department of Pathology, Hospital Sultanah Aminah, Johor Bahru, Johor, Malaysia.
authors.forename: Subathra
authors.initials: S
authors.lastname: Sabaratnam
authors.affiliation: Abbott Diagnostics, Abbott Park, IL, USA.
authors.forename: Sudarshan
authors.initials: S
authors.lastname: Hebbar
authors.affiliation: Abbott Diagnostics, Abbott Park, IL, USA.
authors.forename: Jaganathan
authors.initials: J
authors.lastname: Sickan
authors.affiliation: Abbott Diagnostics, Abbott Park, IL, USA.
authors.forename: Beth A
authors.initials: BA
authors.lastname: Schodin
authors.affiliation: Department of Obstetrics and Gynecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
authors.forename: Chuenkamon
authors.initials: C
authors.lastname: Charakorn
authors.affiliation: Department of Obstetrics and Gynecology, MCU-FDT Medical Foundation, Caloocan, Philippines.
authors.forename: Walfrido W
authors.initials: WW
authors.lastname: Sumpaico
mesh_terms: D000328:Adult; D000465:Algorithms; D014408:Biomarkers, Tumor / Q000097:blood*; D018394:CA-125 Antigen / Q000097:blood; D003661:Decision Support Techniques; D003937:Diagnosis, Differential; D005260:Female; D006801:Humans; D008593:Menopause; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000175:diagnosis* / Q000000981:diagnostic imaging; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011506:Proteins / Q000032:analysis*; D012372:ROC Curve; D018570:Risk Assessment / Q000379:methods; D012680:Sensitivity and Specificity; D014463:Ultrasonography; D000081102:WAP Four-Disulfide Core Domain Protein 2
chemical_list: D014408:Biomarkers, Tumor; D018394:CA-125 Antigen; D011506:Proteins; D000081102:WAP Four-Disulfide Core Domain Protein 2; C569698:WFDC2 protein, human
keywords: Algorithms; CA-125 Antigen; Ovarian Neoplasms; Prospective Studies; Regression Analysis; Sensitivity and Specificity