title: Adding a single CA 125 measurement to ultrasound imaging performed by an experienced examiner does not improve preoperative discrimination between benign and malignant adnexal masses.
abstract: OBJECTIVE
  To determine whether CA 125 measurement is superior to ultrasound imaging performed by an experienced examiner for discriminating between benign and malignant adnexal lesions, and to determine whether adding CA 125 to ultrasound examination improves diagnostic performance.
  
  
  METHODS
  This is a prospective multicenter study (International Ovarian Tumor Analysis (IOTA) study) conducted in nine European ultrasound centers in university hospitals. Of 1149 patients with an adnexal mass examined in the IOTA study, 83 were excluded. Of the remaining 1066 patients, 809 had CA 125 results available and were included. The patients underwent preoperative serum CA 125 measurements and transvaginal ultrasound examination by an experienced ultrasound examiner blinded to CA 125 values. The examiner classified each mass as certainly or probably benign, difficult to classify, or probably or certainly malignant. The outcome measure was the sensitivity and specificity with regard to malignancy of CA 125, ultrasound imaging and their combined use, the 'gold standard' being the histological diagnosis of the adnexal mass removed surgically within 120 days after the ultrasound examination.
  
  
  RESULTS
  There were 242 (30%) malignancies. For 534 tumors judged to be certainly benign or certainly malignant by the ultrasound examiner the sensitivity and specificity of ultrasound examination and CA 125 (> or =35 U/mL indicating malignancy) were 97% vs. 86% (95% CI of difference, 4.7-17.2) and 99% vs. 79% (95% CI of difference, 15.7-24.2); for 209 tumors judged probably benign or probably malignant, sensitivity and specificity were 81% vs. 57% (95% CI of difference, 12.3-36.0) and 91% vs. 74% (95% CI of difference, 8.5-25.7); for 66 tumors that were difficult to classify, sensitivity and specificity were 57% vs. 39% (95% CI of difference, -9.7 to 41.1) and 74% vs. 67% (95% CI of difference, -14.6 to 27.7). Diagnostic performance deteriorated when CA 125 was used as a second-stage test after ultrasound examination.
  
  
  CONCLUSIONS
  Specialist ultrasound examination is superior to CA 125 for preoperative discrimination between benign and malignant adnexal masses, irrespective of the diagnostic confidence of the ultrasound examiner; adding CA 125 to ultrasound does not improve diagnostic performance. Our results indicate that greater investment in education and training in gynecological ultrasound imaging would be of value.
authors: Department of Obstetrics and Gynecology, Malmö University Hospital, Lund University, Malmö SE 20502 , Sweden. lil.valentin@med.lu.se
authors: L
authors: L
authors: Valentin
authors: D
authors: D
authors: Jurkovic
authors: B
authors: B
authors: Van Calster
authors: A
authors: A
authors: Testa
authors: C
authors: C
authors: Van Holsbeke
authors: T
authors: T
authors: Bourne
authors: I
authors: I
authors: Vergote
authors: S
authors: S
authors: Van Huffel
authors: D
authors: D
authors: Timmerman
mesh_terms: D000291:Adnexal Diseases / Q000000981:diagnostic imaging* / Q000503:physiopathology; D000328:Adult; D000368:Aged; D018394:CA-125 Antigen / Q000097:blood*; D003937:Diagnosis, Differential; D005060:Europe; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000000981:diagnostic imaging* / Q000503:physiopathology; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D018608:Ultrasonography, Doppler
chemical_list: D018394:CA-125 Antigen