Optimizing cervical cancer screening for HPV-vaccinated women: Evaluation of post-vaccination cervical cancer screening test

优化接种 HPV 疫苗的女性宫颈癌筛查：疫苗接种后宫颈癌筛查测试的评估

• 批准号: 9806021
• 负责人: Deanna GK Teoh
• 金额: $ 5.48万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-06-01 至 2021-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9806021
• 关键词: Optimizing; cervical; cancer; screening; HPV

ABSTRACT The HPV vaccine is highly effective in clinical trials, with an absolute risk of persistent (6+ months) infection with vaccine-type high-risk HPV of only 1.4% among vaccinated women. As prevalence of HPV infection decreases, the risk of false positive cervical cancer screening results increases. However, current cervical cancer screening guidelines do not differentiate between vaccinated and unvaccinated women. Data cannot be extrapolated from other countries with different HPV vaccination coverage, as cross-protection against non- vaccine type HPV infection varies by population vaccination rates, and are likely to affect screening test performance. Major challenges in development of new U.S. guidelines are anticipated for the following reasons: 1) large U.S. population-based data on HPV infection rates and cervical cancer screening test statistics are currently not available, and likely vary by regional vaccination rates; 2) most studies evaluating cervical cancer screening results in vaccinated women do not differentiate between those who have received only 1 dose of the vaccine and those who have completed the 2-3 dose series; 3) few studies have evaluated differences in outcomes by age at HPV vaccine initiation or interval between doses. The overarching aim of the proposed research is to determine an optimal cervical cancer screening strategy for women vaccinated against HPV. The objectives of this pilot research are to 1) determine if the prevalence of cervical dysplasia has decreased with HPV vaccination and resultantly changed the PPV of cervical cancer screening tests, and 2) determine if cervical cancer screening test performance varies by age at HPV vaccine initiation, number of doses, or interval between HPV vaccine doses. Aim1: Determine if the decrease in prevalence of cervical dysplasia among vaccinated women has resulted in a decrease in the positive predictive value of cervical cancer screening tests. A cross-sectional study will be conducted to compare cervical cancer screening and diagnostic test results among HPV-vaccinated and unvaccinated women. Positive predictive values for positive HPV tests and abnormal cytology results to predict high-grade dysplasia will be compared by HPV vaccination status. Aim2: Determine if cervical cancer screening test accuracy varies by age at vaccine initiation, number of doses received, and/or interval between doses. The positive predictive value of positive HPV tests and abnormal Pap test results among vaccinated women will be compared by the number of vaccine doses received (1 vs. 2+), age at vaccine initiation, and interval between doses using logistic regression.

摘要 HPV疫苗在临床试验中非常有效，具有持续（6个月以上）感染的绝对风险 在接种疫苗的妇女中，疫苗型高危HPV仅占1.4%。由于HPV感染的患病率 随着宫颈癌筛查结果的下降，假阳性的风险增加。然而，目前的宫颈 癌症筛查指南没有区分接种疫苗和未接种疫苗的妇女。数据不能 从其他HPV疫苗接种覆盖率不同的国家推断，作为对非HPV疫苗接种的交叉保护。 疫苗类型HPV感染因人群接种率而异，并可能影响筛查试验 性能预计美国新指南制定过程中将面临以下主要挑战 原因：1）美国基于人口的HPV感染率和宫颈癌筛查试验的大数据 目前没有统计数据，可能因地区疫苗接种率而异; 2）大多数研究评估 接种疫苗的妇女的宫颈癌筛查结果与接受疫苗的妇女没有区别 只有1剂疫苗和那些谁已经完成了2-3剂系列; 3）很少有研究评估 HPV疫苗开始接种时的年龄或接种间隔的结果差异。 拟议研究的总体目标是确定一个最佳的宫颈癌筛查策略， 接种HPV疫苗的妇女。这项试点研究的目的是：1）确定 HPV疫苗接种后宫颈不典型增生减少，结果改变了宫颈癌的PPV 筛查测试，以及2）确定HPV疫苗接种时宫颈癌筛查测试性能是否因年龄而异 开始，剂量或HPV疫苗剂量之间的间隔。 目的1：确定接种疫苗妇女宫颈发育不良患病率的降低是否导致 宫颈癌筛查试验的阳性预测值下降。将进行一项横断面研究， 进行比较HPV疫苗接种者和 未接种疫苗的女性HPV检测阳性和细胞学检查结果异常的阳性预测值 高度异型增生将通过HPV疫苗接种状态进行比较。 目的2：确定宫颈癌筛查测试的准确性是否因疫苗接种时的年龄、接种次数 和/或剂量之间的间隔。HPV检测阳性与巴氏涂片异常的阳性预测价值 接种疫苗的妇女的检测结果将通过接受的疫苗剂量数进行比较（1对2+）， 使用逻辑回归分析疫苗接种开始时的年龄和剂量之间的间隔。