PROGRESS: PRevention of cervical cancer using the Genotyping scREening and Same-day Self-sampling

进展：利用基因分型筛查和当天自我采样预防宫颈癌

• 批准号: 10491481
• 负责人: Miriam Cremer
• 金额: $ 101.13万
• 依托单位: ATILA BIOSYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-05 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10491481
• 关键词: Ablation; Acetic Acids; Address; Age; Artificial Intelligence; Biopsy; Bypass; Caring; Categories; Cellular Phone; Cervical; Cervical Cancer Screening; Cervical Intraepithelial Neoplasia; Cervix Uteri; Characteristics; Clinical; Collection; Colposcopy; Cytology; DNA; Data; Detection; Development; Disease; Disease Progression; Disease model; Eligibility Determination; Evaluation; Female Adolescents; Genotype; Goals; HPV-High Risk; Health; Health Planning Organizations; High Risk Woman; Honduras; Hour; Human Papillomavirus; Human papilloma virus infection; Image; Incidence; Laboratories; Lesion; Low income; Malignant neoplasm of cervix uteri; Mediating; Methods; Modality; Modeling; Oncogenic; Patients; Pelvic Examination; Performance; Point of Care Technology; Predictive Value; Prevalence; Process; Provider; Reporting; Resource-limited setting; Resources; Risk; Sampling; Screening Result; Technology; Testing; TimeLine; Triage; Unnecessary Procedures; Ursidae Family; Vaccinated; Vaccination; Visit; Visual; Woman; World Health Organization; acceptability and feasibility; automated visual evaluation; base; cervical cancer prevention; commercialization; cost; cost effective; cost-effectiveness evaluation; cost-effectiveness ratio; design; digital imaging; follow-up; high risk; incremental cost-effectiveness; innovation; isothermal amplification; low and middle-income countries; member; mortality; overtreatment; performance tests; premalignant; screening; secondary analysis; treatment duration

PROJECT SUMMARY In 2018, the World Health Organization (WHO) called for action towards achieving the global elimination of cervical cancer. Member states ratified a strategy for achieving this goal in August 2020. The WHO plan calls for an aggressive approach of vaccination, screening, and treatment of the human papillomavirus (HPV), the single cause of cervical cancer. In low- and middle-income countries (LMIC), which bear 90% of the incidence and mortality of cervical cancer globally, it is estimated that these goals will not be reached until 2120 – a century from now. One way to shorten this timeline is through HPV self-sampling and immediate treatment for those at the highest risk of developing invasive disease. This will only be possible through a low-cost and effective test that is easy to use in the field, combined with triage strategies that channel women to treatment but avoid unnecessary procedures that drain limited resources. The modified AmpFire® HPV Genotyping test (Atila Biosystems, CA) is a new test that identifies 13 high-risk HPV types and stratifies them by oncogenic risk into four groups. AmpFire® relies on loop-mediated isothermal amplification (LAMP) rather than DNA extraction, thus allowing for small-batch processing in 1-2 hours at a low cost per sample. No other HPV test has these characteristics, which allow for the development of same-day screen-and-treat strategies that can triage women at the highest risk, reduce loss to follow-up, and decrease overtreatment. Furthermore, the modified AmpFire® has demonstrated high sensitivity in self-collected samples. The purpose of this study is to evaluate the performance of this in the detection of high-grade precancer (cervical intraepithelial neoplasia, grade 2 or higher, or CIN2+). We will also pilot a same-day screen-and-treat strategy using AmpFire® and Automated Visual Assessment (AVE), an artificial intelligence triage method based on an assessment of cervical images captured with an ordinary smartphone. Thus, this study will accomplish the following Specific Aims: Specific Aim 1: To estimate the test performance of self- and provider- collected modified AmpFire® screening platform in Honduras; Specific Aim 2: To evaluate the feasibility of a single visit approach using a self-sampled modified AmpFire® screening platform; Specific Aim 3: Evaluate the cost-effectiveness of the same-day screen-and-treat approach using the modified AmpFire® test followed by triage with Automated Visual Evaluation (AVE) versus the current strategy in Honduras.

项目总结