title: Urinary concentrations of human epidydimis secretory protein 4 (He4) in the diagnosis of ovarian cancer: a case--control study.
abstract: OBJECTIVE
  To analyze differential diagnostic accuracy of urinary human epidydimis secretory protein 4 (HE4) in patients with ovarian tumors.
  
  
  METHODS
  In the case-control study 23 patients with ovarian cancer, 37 patients with benign ovarian tumors and 18 women in the control group were included. Serum CA125 values and urinary concentrations of HE4were assessed quantitatively. Urinary creatinine concentrations and glomerular filtration rate were also determined and used to calculate ratios to HE4.
  
  
  RESULTS
  Higher urinary HE4 concentrations were observed in patients with late stage ovarian cancer (p=0.001) and also in patients with early stage ovarian cancer when compared to patients with benign ovarian tumors (p=0.044). On analysis where all ovarian cancer patients were included, higher diagnostic accuracy was observed with calculated ratio of HE4 to glomerular filtration rate (GFR) to unchanged urinary HE4 concentrations -AUC 0.861 vs. 0.858. When discriminatory accuracy was calculated for urinary HE4/GFR ratio and unchanged urinary HE4 concentrations, the last demonstrated a higher area under the curve - 0.701 vs. 0.602. The urinary HE4/creatinine ratio had lower discriminatory characteristics than unchanged concentrations of urinary HE4. However, HE4 serum concentration was more accurate for discrimination of patients with benign and malignant ovarian tumors when compared to urinary HE4 and CA125 in sera (AUCs were 0.868 for serum HE4 and 0.856 and 0.653 for urinary HE4 and CA125, respectively).
  
  
  CONCLUSIONS
  Ovarian cancer patients have higher urinary concentrations of human epidydimis secretory protein 4 than patients with benign ovarian tumors. Urinary HE4 has comparable discriminatory accuracy with serum HE4 for benign and malignant ovarian tumors and can be recommended as a non-invasive ovarian cancer risk assessment method.
authors.affiliation: Department of Gynecology and Obstetrics of Riga Stradins University, Riga, Latvia. r.macuks@gmail.com
authors.forename: Ronalds
authors.initials: R
authors.lastname: Macuks
authors.forename: Ieva
authors.initials: I
authors.lastname: Baidekalna
authors.forename: Simona
authors.initials: S
authors.lastname: Donina
mesh_terms: D019540:Area Under Curve; D014408:Biomarkers, Tumor / Q000652:urine*; D018394:CA-125 Antigen / Q000097:blood; D016022:Case-Control Studies; D003404:Creatinine / Q000652:urine; D003937:Diagnosis, Differential; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D010051:Ovarian Neoplasms / Q000097:blood / Q000175:diagnosis* / Q000473:pathology / Q000652:urine*; D011506:Proteins / Q000378:metabolism*; D012372:ROC Curve; D016482:Urinalysis; 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; D003404:Creatinine