Cytology vs at home HPV screening for detection of CIN 2,3,CIS

细胞学与家庭 HPV 筛查检测 CIN 2,3,CIS

• 批准号: 8520259
• 负责人: Nancy B. Kiviat
• 金额: $ 57.65万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-24 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8520259
• 关键词: Adoption; Atypical Squamous Cell; Biological Assay; Biological Markers; Biopsy; Cancer Control; Carcinoma; Carcinoma in Situ; Cervical Intraepithelial Neoplasia; Clinic; Clinical Trials; Colposcopy; Country; Cytology; DNA; Data; Databases; Detection; Development; Electronics; Enrollment; Epigenetic Process; Genes; Genital system; Genotype; HPV-High Risk; Home environment; Human Papilloma Virus Vaccine; Human Papillomavirus; Human papillomavirus 16; Infection; Interview; Malignant neoplasm of cervix uteri; Pap smear; Participant; Performance; Population; Prevalence; Prevention; Public Health; Randomized Clinical Trials; Recording of previous events; Records; Relative (related person); Sampling; Sensitivity and Specificity; Site; Testing; Triage; Universities; Vaccinated; Vaccination; Vaccines; Washington; Woman; arm; base; clinical practice; cost; cost effective; cost effectiveness; novel; novel strategies; population based; prophylactic; sample collection; screening; vaccine evaluation; willingness to pay

DESCRIPTION (provided by applicant): We propose to conduct a randomized clinical trial among women who have/have not been vaccinated against HPV 16/18, to compare the sensitivity, specificity, cost-effectiveness and acceptability of screening for CIN 2- 3/CIS using the currently recommended cytology-based screening approach and a novel approach in which self collected samples are tested for high risk (HR)-HPV DNA followed by in-clinic cytology for triage of HR- HPV positive women to colposcopy. We will also explore the potential utility of triage of HR-HPV positive women by HPV genotyping and/or detection of epigenetic changes. The significance of the proposed study is that despite the availability of prophylactic HPV 16/18 vaccines, screening will need to continue and although, in the absence of a vaccine, cytology based screening was highly effective, cost-effectiveness analyses suggest that the incremental cost-effectiveness ratio of adding vaccination to cytology-based screening will far exceed commonly-cited willingness to pay thresholds. Further, the PPV of cytology will be decreased among HPV vaccinated women. Studies in other countries suggest that HPV based screening the cytology based triage will be more sensitive and specific than cytology based screening even among women vaccinated against HR-HPV. The study is novel as HPV screening with cytology triage has not been examined in relationship to vaccination, or in combination with home based collection of specimens. Further, HPV based screening with cytology triage has not yet been examined in US based populations, and, unlike previous, we will determine the absolute, rather than the relative, sensitivity and specificity of each approach, and carry out cost effectiveness analyses based on data collected from study participants immediately after they complete screening. The potential impact of demonstrating the utility of this novel approach is the eventual widespread adoption of a more cost effective approach to CCC, appropriate to the era of HPV vaccines. Dr. Kiviat, Kulasingam, Hawes, Feng and Emerson have proven track records for successfully carrying out large, clinical trials and cost-effectiveness analyses which have challenged/changed clinical practice paradigms of CCC.

描述（由申请人提供）：我们建议在已接种/未接种 HPV 16/18 疫苗的女性中进行一项随机临床试验，以比较使用当前推荐的基于细胞学的筛查方法和一种新颖的方法筛查 CIN 2-3/CIS 的敏感性、特异性、成本效益和可接受性，在该方法中，对自行收集的样本进行高风险 (HR)-HPV DNA 检测，然后进行临床细胞学检查 对 HR-HPV 阳性女性进行阴道镜检查分类。我们还将探讨通过 HPV 基因分型和/或检测表观遗传变化对 HR-HPV 阳性女性进行分类的潜在效用。拟议研究的意义在于，尽管有预防性 HPV 16/18 疫苗，但筛查仍需要继续进行，尽管在没有疫苗的情况下，基于细胞学的筛查非常有效，但成本效益分析表明，在基于细胞学的筛查中添加疫苗接种的增量成本效益比将远远超过普遍引用的支付意愿阈值。此外，接种 HPV 疫苗的女性的细胞学 PPV 会降低。其他国家的研究表明，即使在接种 HR-HPV 疫苗的女性中，基于细胞学分类的 HPV 筛查也比基于细胞学的筛查更加敏感和特异。这项研究是新颖的，因为细胞学分类的 HPV 筛查尚未与疫苗接种或与家庭标本采集相结合进行检查。此外，基于 HPV 的细胞学分类筛查尚未在美国人群中得到检验，与以前不同的是，我们将确定每种方法的绝对敏感性和特异性，而不是相对敏感性和特异性，并根据研究参与者完成筛查后立即收集的数据进行成本效益分析。展示这种新方法的实用性的潜在影响是最终广泛采用一种更具成本效益的 CCC 方法，适合 HPV 疫苗时代。 Kiviat 博士、Kulasingam、Hawes、Feng 和 Emerson 拥有成功开展大型临床试验和成本效益分析的良好记录，这些记录挑战/改变了 CCC 的临床实践范式。