Prevalence of cervical cancer and feasibility of screening in rural China: a pilot study for the Shanxi Province Cervical Cancer Screening Study.
For cervical cancer screening to be feasible in developing countries, it must be accurate, inexpensive, and easy to administer. We conducted a pilot study in rural Shanxi Province, People's Republic of China, to determine disease prevalence and study feasibility in preparation for a large-scale comparative trial of 6 screening tests. One-hundred and thirty-six nonpregnant women with no history of hysterectomy, pelvic radiation, or Papanicolaou tests were screened in a rural clinic. Ten percent of the women enrolled reported abnormal vaginal bleeding and 45% reported abnormal vaginal discharge. The tests were the Papanicolaou test (both conventional and ThinPrep), a self-administered swab test by Hybrid Capture II for high-risk human papillomavirus (HPV), a test for high-risk HPV from residual PreservCyt medium, fluorescence spectroscopy, and visual inspection of the cervix by a clinician. All women also underwent colposcopy and biopsies as the reference standard. Biopsies showed 12 of 136 women had >/= high-grade squamous intraepithelial lesions (HGSIL). Screening was completed in 5 half-day sessions, the procedures went smoothly, and local cooperation was enthusiastic. Disease prevalence in Xiangyuan and Yangcheng Counties, Shanxi Province, can be estimated at 8.8% (95% CI, 4.5% to 15.0%). Screening 1000-2000 patients would be sufficient to detect a 10% difference in accuracy between diagnostic tests. The proposed large-scale trial is feasible.
Department of Gynecology & Obstetrics, The Cleveland Clinic Foundation, Cleveland, Ohio;Cancer Institute/Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China;Department of Gynecologic Oncology and Pelvic Surgery, Kaiser Permanente, Fontana, California;Department of Biostatistics, Cleveland Clinic Foundation, Cleveland, Ohio;Optical Biopsy Tech. LLC, Knoxville, Tennessee;Digene Corporation, Silver Spring, Maryland;Cytyc Corporation, Boxborough, Massachusetts;Neopath Inc., Redmond, Washington;Department of Anatomic Pathology, The Cleveland Clinic Foundation, Cleveland, Ohio;Cancer Hospital, Yangcheng County, Shanxi Province, People's Republic of China; and Women and Children Health Station, Xiangyuan County, Shanxi Province, People's Republic of China.
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