title: Significance of adding progesterone to the Risk of Ovarian Malignancy Algorithm for early stage ovarian cancer detection in patients with a pelvic mass: A single-center case-control study.
abstract: OBJECTIVE
  To evaluate the clinical significance of the combination of cancer antigen-125 (CA-125), human epididymis protein 4 (HE4), and progesterone for the identification of ovarian masses in patients with suspected early stage ovarian cancer (OC).
  
  
  METHODS
  This was a case-control, single-center study of 225 women with a pelvic mass of suspected ovarian origin, including 75 patients with Stage I/II OC and 150 controls. Diagnostic procedures included pelvic and rectal examinations, transvaginal ultrasound, evaluation of CA-125 and HE4 levels alone and in the Risk of Ovarian Malignancy Algorithm (ROMA), and a new algorithm combining ROMA and progesterone.
  
  
  RESULTS
  Median CA-125 and HE4 levels were significantly higher in patients with OC compared with women with benign ovarian tumors, irrespective of menopausal status. The highest median progesterone levels occurred in premenopausal women with benign ovarian tumors, compared with premenopausal women with OC with or without benign ovarian disease. The combination of ROMA and progesterone was significantly more accurate at detecting OC compared with ROMA or CA-125 or HE4 alone, but only in premenopausal patients.
  
  
  CONCLUSIONS
  Different algorithms should be used for diagnosing OC, and the addition of progesterone might improve the performance of ROMA for the diagnosis of pelvic masses in premenopausal women.
authors.affiliation: Department of Gynecological Oncology, Jagiellonian University, Krakow, Poland. Electronic address: kazimierz.pitynski@uj.edu.pl.
authors.forename: Kazimierz
authors.initials: K
authors.lastname: Pitynski
authors.affiliation: Department of Gynecological Oncology, Jagiellonian University, Krakow, Poland.
authors.forename: Agnieszka
authors.initials: A
authors.lastname: Sporek
authors.affiliation: Department of Gynecological Oncology, Jagiellonian University, Krakow, Poland.
authors.forename: Iga
authors.initials: I
authors.lastname: Lipinska
authors.affiliation: Department of Gynecological Oncology, Jagiellonian University, Krakow, Poland.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Banas
authors.affiliation: Department of Gynecological Oncology, Jagiellonian University, Krakow, Poland.
authors.forename: Artur
authors.initials: A
authors.lastname: Ludwin
authors.affiliation: Department of Gynecological Oncology, Jagiellonian University, Krakow, Poland.
authors.forename: Marta
authors.initials: M
authors.lastname: Bałajewicz-Nowak
mesh_terms: D000465:Algorithms; D014408:Biomarkers, Tumor / Q000097:blood; D018394:CA-125 Antigen / Q000097:blood*; D016022:Case-Control Studies; D055088:Early Detection of Cancer; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000097:blood* / Q000175:diagnosis*; D017697:Premenopause; D011374:Progesterone / Q000097:blood*; D011506:Proteins / Q000032:analysis*; 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; D011374:Progesterone
keywords: ROMA; cancer antigen-125; human epididymis protein 4; ovarian cancer; progesterone