A randomized study of screening for ovarian cancer: a multicenter study in Japan

Abstract

Ovarian cancer is common in women from developed countries. We designed a prospective randomized controlled trial of ovarian cancer screening to establish an improved strategy for the early detection of cancers. Asymptomatic postmenopausal women were randomly assigned between 1985 and 1999 to either an intervention group (n = 41,688) or a control group (n = 40,799) in a ratio of 1:1, with follow-up of mean 9.2 years, in Shizuoka district, Japan. The original intention was to offer women in the intervention group annual screens by gynecological examination (sequential pelvic ultrasound [US] and serum CA125 test). Women with abnormal US findings and/or raised CA125 values were referred for surgical investigation by a gynecological oncologist. In December 2002, the code was broken and the Shizuoka Cohort Study of Ovarian Cancer Screening and Shizuoka Cancer Registry were searched to determine both malignant and nonmalignant diagnoses. Twenty-seven cancers were detected in the 41,688-screened women. Eight more cancers were diagnosed outside the screening program. Detection rates of ovarian cancer were 0.31 per 1000 at the prevalent screen and 0.38-0.74 per 1000 at subsequent screens; they increased with successive screening rounds. Among the 40,779 control women, 32 women developed ovarian cancer. The proportion of stage I ovarian cancer was higher in the screened group (63%) than in the control group (38%), which did not reach statistical significance (P = 0.2285). This is to our knowledge the first prospective randomized report of the ovarian cancer screening. The rise in the detection of early-stage ovarian cancer in asymptomatic postmenopausal women is not significant, but future decisions on screening policy should be informed by further follow-up from this trial.

Stem‐Like Epithelial Cells Are Concentrated in the Distal End of the Fallopian Tube: A Site for Injury and Serous Cancer Initiation

“…Although MUC16 (CA 125) is the best-known tumor marker for serous cancers [34,49], multiple clinical trials have shown it is a poor biomarker for early detection and screening [50][51][52]. In fact to date, no reliable tumor marker has been identified for screening of this deadly disease.…”

Early Detection of Ovarian Tumors Using Ultrasound

“…Kentucky trial [21] PLCO trial [22] UKCTOCS trial [23] SCSOCS trial [24] Country USA USA UK Japan has indicated that 19.5 nonmalignancies went to surgery for each malignancy [25]. Lastly, the Kentucky trial found a significant survival benefit to TVS screening, while the PLCO trial reported similar mortalities in the screened and control group.…”

“…While randomized controlled trials are very powerful, there are settings that challenge them and ovarian cancer screening can be one of these settings. There are four published trials that summarize findings on the use of ultrasound for the early detection of ovarian tumors: the Kentucky trial [21], the PLCO trial [22], the UKCTOCS [23] and the SCSOCS trial [24]. It should be noted that a separate UKFOCSS for high-risk women is underway in the UK.…”

In vivo magnetic resonance spectroscopy for ovarian cancer diagnostics: quantification by the fast Padé transform

“…Therefore, the conclusion was that this screening strategy should not be recommended [22]. Concordantly, the conclusion of a randomized multi-center study of 48027 women from Japan [Shizuoka Cohort Study on Ovarian Cancer Screening (SCSOCS)] was that TVUS plus CA-125 did not lead to a significant increase in stage I ovarian cancer detection among asymptomatic women who had passed menopause [23]. Notably, among the 40801 women enrolled in the SCSOCS who never had a CA-125 value above the upper limit of normal (35 Units/mL), some 4859 women had an abnormal TVUS.…”