title: A 2-stage ovarian cancer screening strategy using the Risk of Ovarian Cancer Algorithm (ROCA) identifies early-stage incident cancers and demonstrates high positive predictive value.
abstract: BACKGROUND
  A 2-stage ovarian cancer screening strategy was evaluated that incorporates change of carbohydrate antigen 125 (CA125) levels over time and age to estimate risk of ovarian cancer. Women with high-risk scores were referred for transvaginal ultrasound (TVS).
  
  
  METHODS
  A single-arm, prospective study of postmenopausal women was conducted. Participants underwent an annual CA125 blood test. Based on the Risk of Ovarian Cancer Algorithm (ROCA) result, women were triaged to next annual CA125 test (low risk), repeat CA125 test in 3 months (intermediate risk), or TVS and referral to a gynecologic oncologist (high risk).
  
  
  RESULTS
  A total of 4051 women participated over 11 years. The average annual rate of referral to a CA125 test in 3 months was 5.8%, and the average annual referral rate to TVS and review by a gynecologic oncologist was 0.9%. Ten women underwent surgery on the basis of TVS, with 4 invasive ovarian cancers (1 with stage IA disease, 2 with stage IC disease, and 1 with stage IIB disease), 2 ovarian tumors of low malignant potential (both stage IA), 1 endometrial cancer (stage I), and 3 benign ovarian tumors, providing a positive predictive value of 40% (95% confidence interval = 12.2%, 73.8%) for detecting invasive ovarian cancer. The specificity was 99.9% (95% confidence interval = 99.7%, 100%). All 4 women with invasive ovarian cancer were enrolled in the study for at least 3 years with low-risk annual CA125 test values prior to rising CA125 levels.
  
  
  CONCLUSIONS
  ROCA followed by TVS demonstrated excellent specificity and positive predictive value in a population of US women at average risk for ovarian cancer.
authors: Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors: Karen H
authors: KH
authors: Lu
authors: Steven
authors: S
authors: Skates
authors: Mary A
authors: MA
authors: Hernandez
authors: Deepak
authors: D
authors: Bedi
authors: Therese
authors: T
authors: Bevers
authors: Leroy
authors: L
authors: Leeds
authors: Richard
authors: R
authors: Moore
authors: Cornelius
authors: C
authors: Granai
authors: Steven
authors: S
authors: Harris
authors: William
authors: W
authors: Newland
authors: Olasunkanmi
authors: O
authors: Adeyinka
authors: Jeremy
authors: J
authors: Geffen
authors: Michael T
authors: MT
authors: Deavers
authors: Charlotte C
authors: CC
authors: Sun
authors: Nora
authors: N
authors: Horick
authors: Herbert
authors: H
authors: Fritsche
authors: Robert C
authors: RC
authors: Bast
mesh_terms: D000368:Aged; D000465:Algorithms; D018394:CA-125 Antigen / Q000097:blood*; D055088:Early Detection of Cancer / Q000379:methods; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000097:blood* / Q000453:epidemiology / Q000473:pathology; D017698:Postmenopause / Q000097:blood; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012307:Risk Factors; D014481:United States / Q000453:epidemiology
chemical_list: D018394:CA-125 Antigen
keywords: CA125; cancer screening; ovarian cancer screening; positive predictive value; transvaginal ultrasound
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