Abstract
Objective In the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO), ovarian cancer screening with transvaginal ultrasound (TVU) and CA-125 produced a large number of false-positive tests. We examined relationships between histopathologic diagnoses, false-positive test group, and participant and screening test characteristics. Methods The PLCO ovarian cancer screening arm included 39,105 women aged 55–74 years assigned to annual CA-125 and TVU. Histopathologic diagnoses from women with false-positive tests and subsequent surgery were reviewed in this analysis: all CA125+ ( n = 121); all CA125+/TVU+ ( n = 46); and a random sample of TVU+ ( n = 373). Demographic and ovarian cancer risk factor data were self-reported. Pathologic diagnoses were abstracted from surgical pathology reports. We compared participant characteristics and pathologic diagnoses by category of false-positive using Pearson χ 2, Fisher's exact, or Wilcoxon–Mann–Whitney tests. Results Women with a false-positive TVU were younger ( P < 0.001), heavier ( P < 0.001), and reported a higher frequency of prior hysterectomy ( P < 0.001). Serous cystadenoma, the most common benign ovarian diagnosis, was more frequent among women with TVU+ compared to CA-125+ and CA-125+/TVU+ ( P < 0.001). Benign non-ovarian findings were commonly associated with all false-positive s, although more frequently with CA-125+ than TVU+ or CA-125+/TVU+ groups ( P = 0.019). Non-ovarian cancers were diagnosed most frequently among CA-125+ ( P < 0.001). Conclusions False-positive ovarian cancer screening tests were associated with a range of histopathologic diagnoses, some of which may be related to patient and screening test characteristics. Further research into the predictors of false-positive ovarian cancer screening tests may aid efforts to reduce false-positive results.
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