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: 8079420
• 负责人: Nancy B. Kiviat
• 金额: $ 65.8万
• 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/8079420
• 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; Screening procedure; 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; 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. PUBLIC HEALTH RELEVANCE: Developing novel sensitive, specific and cost effective approaches to cervical cancer control (CCC) for women who have/have not received the HPV vaccine is of great public health importance. This study will compare our current Pap smear based screening approach for cervical cancer control, to cervical cancer control using home based HPV screening assays. This novel approach would more cost effective than currently recommended approaches.

描述（申请人提供）：我们建议在已经/没有接种HPV 16/18疫苗的妇女中进行一项随机临床试验，比较HPV 16/18疫苗的敏感性、特异性，使用目前推荐的基于细胞学的筛查方法和一种新方法（其中自我收集的样本进行高风险（HR）检测）筛查CIN 2- 3/CIS的成本效益和可接受性-HPV DNA，随后进行门诊细胞学检查，以便将HR-HPV阳性女性分诊至阴道镜检查。我们还将探讨通过HPV基因分型和/或检测表观遗传学变化对HR-HPV阳性女性进行分诊的潜在效用。拟议研究的重要性在于，尽管预防性HPV 16/18疫苗可用，但筛查仍需继续，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，将疫苗接种添加到基于细胞学的筛查中的增量成本效益比将远远超过常见的支付意愿阈值。此外，HPV疫苗接种妇女的细胞学PPV将降低。其他国家的研究表明，即使在接种HR-HPV疫苗的妇女中，基于HPV的筛查（基于细胞学的分诊）也比基于细胞学的筛查更敏感和特异。该研究是新颖的，因为尚未检查HPV筛查与细胞学分诊与疫苗接种的关系，或与家庭标本采集相结合。此外，基于HPV的筛查与细胞学分诊尚未在美国人群中进行检查，与以前不同的是，我们将确定每种方法的绝对灵敏度和特异性，而不是相对灵敏度和特异性，并根据从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。证明这种新方法的实用性的潜在影响是最终广泛采用适合HPV疫苗时代的更具成本效益的CCC方法。Kiviat博士、Kulasingam博士、Hawes博士、Feng博士和Emerson博士在成功开展大型临床试验和成本效益分析方面有着良好的记录，这些试验和分析挑战/改变了CCC的临床实践范式。 公共卫生关系：开发新的敏感，特异性和成本效益的方法来控制宫颈癌（CCC）的妇女谁/没有收到HPV疫苗是非常重要的公共卫生。这项研究将比较我们目前的宫颈癌控制的巴氏涂片筛查方法，宫颈癌控制使用家庭为基础的HPV筛查检测。这种新方法比目前推荐的方法更具成本效益。