Comparison of Three Management Strategies for Patients With Atypical Squamous Cells of Undetermined Significance: Baseline Results From a Randomized Trial

摘要: Background: More than 2 million U.S. women receive an equivocal cervical cytologic diagnosis (atypical squamous cells of undetermined significance [ASCUS]) each year. Effective colposcopy triage strategies are needed to identify the minority who have clinically significant disease while avoiding excessive follow-up evaluation for others. Methods: The ASCUS/LSIL (i.e., low-grade intraepithelial lesion) Triage Study (ALTS) is a multicenter, randomized trial comparing sensitivity and specificity following three management detect neoplasia grade 3 (CIN3): 1) immediate (considered be reference standard), 2) based on human papillomavirus (HPV) results from Hybrid Capture 2™ (HC thin-layer cytology results, or 3) alone. This article summarizes cross-sectional enrollment 3488 with referral ASCUS. All statistical tests two-sided. Results: Among participants ASCUS, underlying prevalence histologically confirmed CIN3 was 5.1%. Sensitivity above by testing cancer-associated HPV DNA 96.3% (95% confidence interval [CI] = 91.6% 98.8%), 56.1% referred colposcopy. single repeat specimen threshold HSIL 44.1% CI 35.6% 52.9%), 6.9% referred. lower ASCUS 85.3% 78.2% 90.8%), 58.6% Conclusions: HC viable option in It has greater comparable additional test indicating above. [J Natl Cancer Inst 2001;93:293–9]