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: 8324186
• 负责人: Nancy B. Kiviat
• 金额: $ 62.88万
• 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/8324186
• 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.

描述（由申请人提供）：我们建议对尚未/尚未接种HPV接种HPV 16/18接种的女性进行随机临床试验，以比较CIN 2- 3/CIS筛查的敏感性，特异性，成本效益和可接受性，并使用基于细胞学的筛查方法和针对自我收集的样品进行了cin cy cy的样品（HR）（HR）（HR）（HR）的新型方法（HR） HR-HPV阳性女性与阴道镜的分类。我们还将通过HPV基因分型和/或检测表观遗传变化来探讨HR-HPV阳性女性分类的潜在效用。拟议的研究的重要性是，尽管预防性HPV 16/18疫苗的可用性仍需要继续，但尽管在没有疫苗的情况下，基于细胞学的筛查是高效，成本效益分析的高度有效，成本效益分析表明，增量成本效益比基于细胞学的筛查的增量效果越来越多，远远超出了持续的筛查性。此外，HPV接种妇女的细胞学PPV将减少。在其他国家的研究表明，基于HPV的基于细胞学的分类将比基于细胞学的筛查更敏感和特异性，即使在接种HR-HPV接种的女性中，基于细胞学的筛查也将更加敏感和特异性。这项研究是新颖的，因为与疫苗接种关系或与基于家庭的样品的收集结合，尚未对HPV筛查进行细胞学分类筛查。此外，在美国人群中尚未对基于HPV的基于HPV进行筛查，与以前的人群不同，我们将根据研究参与者立即在完成筛选后立即根据研究参与者立即从研究参与者中收集的数据来确定每种方法的相对，敏感性和特异性，并进行成本效益分析。证明这种新颖方法的实用性的潜在影响是最终采用了适合HPV疫苗时代的更具成本效益的CCC方法。 Kiviat博士，Kulasingam，Hawes，Feng和Emerson成功地进行了记录，成功地进行了大型临床试验和成本效益分析，这些分析挑战/改变了CCC的临床实践范式。