Performance of different sample types for high-risk human papillomavirus testing and genotyping for the detection of high grade cervical intraepithelial neoplasia
不同样本类型用于高危人乳头瘤病毒检测和高级别宫颈上皮内瘤变检测基因分型的性能
基本信息
- 批准号:10623831
- 负责人:
- 金额:$ 12.5万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2020
- 资助国家:美国
- 起止时间:2020-08-13 至 2025-07-31
- 项目状态:未结题
- 来源:
- 关键词:AdolescentAfrica South of the SaharaAgeCervicalCervical Intraepithelial NeoplasiaCervix UteriCessation of lifeCountryDetectionDiseaseEnrollmentFemaleFemale AdolescentsFundingFutureGenotypeGoalsHIVHPV-High RiskHealth PersonnelHourHuman Papilloma Virus VaccinationHuman PapillomavirusHuman papilloma virus infectionImmunization ProgramsIndividualMalawiMalignant neoplasm of cervix uteriMethylationNucleic AcidsPerformancePrevalencePrevention strategyProviderPublic HealthResearch Project GrantsRiskSamplingSwabSystemTechnologyTest ResultTestingThermal Ablation TherapyTreatment FailureTriageUrineVaccinesVulnerable PopulationsWomancervical cancer preventioncervicovaginalcostfollow-upinstrumentinterestlow and middle-income countriesmortalityportabilitypremalignantpreventprogramsresponsescreeningunvaccinated
项目摘要
ABSTRACT
This application is being submitted in response to the Notice of Special Interest (NOSI) identified as NOT-CA-
22-036. Invasive cervical cancer (ICC) remains a public health problem among vulnerable populations in both
high and low-and-middle income countries (LMICs).1 Annually, about 342,000 die from ICC worldwide, with over
85% of deaths occurring in LMICs.1 ICC is preventable through human papillomavirus (HPV) vaccination,
screening, and treatment for cervical intraepithelial neoplasia 2 or higher (CIN2+).2 However, access to these
ICC prevention strategies remains limited, particularly in LMICs, and is compounded in sub-Saharan Africa (SSA)
by HIV since women living with HIV (WLWH) are at increased risk of persistent HPV infection, cervical
intraepithelial neoplasia 2 or higher (CIN2+), and ICC.3–5 Malawi, a country in SSA, has the world’s highest ICC
mortality.6 HIV prevalence is 11% among females age 15-49 years,7 and HPV infection is currently estimated at
39% among WLWH.8 In 2019, Malawi launched a national HPV vaccination program for adolescent girls following
a pilot demonstration project.9,10 However, for the near future, most Malawian women will be vaccine-ineligible
due to their age and thus will remain unvaccinated. Even if widespread HPV vaccination of adolescents is
achieved, the consequent decline in ICC mortality is not anticipated for decades.
Rapid HPV testing is attracting interest as it allows for same day screen-and-treat strategies for ICC prevention.
The AmpFire® HPV Genotyping System is a unique nucleic acid amplification technology developed by Atila
Biosystems, Inc. that genotypes 15 hrHPV subtypes.23,24 It uses a low-cost portable instrument that provides
HPV test results in approximately one hour and can be used on dry swabs. Thus, hrHPV genotyping for same-
day HPV screen-and-treat programs in LMICs is feasible with AmpFire®. Therefore, for this supplemental
research project, we plan to evaluate the performance of different sample types for hrHPV testing using
AmpFire® HPV genotyping and explore which individual genotypes by sample type have the highest
sensitivity for CIN2+ among a subset of 331 hrHPV+ among the 627 WLWH in Lilongwe, Malawi. These
women are already enrolled and being followed up in our U54-funded study (U54CA254564), which evaluates
the performance of another potential triage test, S5 methylation, for the detection of CIN2+ in WLWH.25
To achieve our goals, we have the following Specific Aims: Aim 1: Evaluate and compare urine, self-
collected cervicovaginal, and provider-collected cervical samples for the detection of different high-risk
HPV genotypes among WLWH. Aim 2: Explore which individual hrHPV genotypes detected on urine,
self-collected cervicovaginal, and provider-collected cervical samples have the highest sensitivity for
detecting CIN2+. Aim 3: Explore which individual hrHPV genotypes detected on urine, self-collected
cervicovaginal, and provider-collected cervical samples are associated with thermal ablation treatment
failure.
摘要
本申请是为了回应被确认为非CA-CA的特殊利益通知(NOSI)而提交的
22-036。浸润性宫颈癌(ICC)在这两个地区的脆弱人群中仍然是一个公共卫生问题
1每年全世界约有342,000人死于国际刑事法院,其中
85%的死亡发生在LMICs1 ICC可通过接种人类乳头瘤病毒(HPV)疫苗预防,
宫颈上皮内瘤变2级或更高级别的筛查和治疗(CIN2+).2然而,获得这些
国际刑事法院的预防战略仍然有限,特别是在小岛屿发展中国家,而且在撒哈拉以南非洲(SSA)也是如此。
由于艾滋病毒携带者(WLWH)妇女持续感染HPV的风险增加,宫颈
上皮内瘤变2级或更高(CIN2+),而ICC.3-5马拉维是SSA中的一个国家,拥有世界上最高的ICC
6艾滋病毒在15-49岁女性中的感染率为11%,7人乳头瘤病毒感染目前估计为
8马拉维于2019年为以下青春期女孩启动了全国人乳头状瘤病毒疫苗接种方案
试点示范项目。9,10然而,在不久的将来,大多数马拉维妇女将不符合接种疫苗的条件
由于他们的年龄,因此将继续不接种疫苗。即使青少年普遍接种HPV疫苗
尽管如此,国际刑事法院死亡率的下降预计在几十年内不会出现。
快速HPV检测吸引了人们的兴趣,因为它允许在同一天进行ICC预防的筛查和治疗策略。
AmpFire®HPV基因分型系统是Atila开发的一项独特的核酸扩增技术
BiosSystems,Inc.对15个hrHPV亚型进行基因分型。23,24它使用一种低成本的便携式仪器,提供
HPV检测结果大约需要一小时,可用于干拭子。因此,hrHPV基因分型对同一-
使用AmpFire®,LMIC中的日间HPV筛选和治疗计划是可行的。因此,对于这份补充材料
研究项目,我们计划评估不同类型的样本用于hrHPV检测的性能,使用
AmpFire®HPV基因分型,并探索样本类型中哪些个体的基因型别最高
马拉维利隆圭627个WLWH中331个hrHPV+的子集对CIN2+的敏感性。这些
女性已经在我们的U54资助的研究(U54CA254564)中登记并接受跟踪,该研究评估
另一种潜在的分类测试,S5甲基化,用于检测WLWH.25中的CIN2+
为了实现我们的目标,我们有以下具体目标:目标1:评估和比较尿液,自我
采集宫颈阴道标本和提供者采集的宫颈样本用于检测不同高危人群
WLWH中的HPV基因分型。目的2:探讨在尿液中检测到哪些个体hrHPV基因型别,
自我采集的宫颈阴道样本和提供者收集的宫颈样本对
正在检测CIN2+。目的3:探索自己收集的尿液中检测到哪些hrHPV基因类型
宫颈阴道和提供者收集的宫颈样本与热消融治疗有关
失败了。
项目成果
期刊论文数量(0)
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会议论文数量(0)
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Carla J Chibwesha其他文献
Carla J Chibwesha的其他文献
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{{ truncateString('Carla J Chibwesha', 18)}}的其他基金
Partnership for advancing cervical cancer prevention in women living with HIV (CASCADE - Research Hub)
促进艾滋病毒感染女性宫颈癌预防的伙伴关系(CASCADE - 研究中心)
- 批准号:
10544391 - 财政年份:2022
- 资助金额:
$ 12.5万 - 项目类别:
Partnership for advancing cervical cancer prevention in women living with HIV (CASCADE - Research Hub)
促进艾滋病毒感染女性宫颈癌预防的伙伴关系(CASCADE - 研究中心)
- 批准号:
10707249 - 财政年份:2022
- 资助金额:
$ 12.5万 - 项目类别:
The road to recovery: An assessment of patient-reported quality of life among cancer survivors in Malawi.
康复之路:对马拉维癌症幸存者患者报告的生活质量的评估。
- 批准号:
10428019 - 财政年份:2020
- 资助金额:
$ 12.5万 - 项目类别:
Innovations for screening and prognosis in HIV+ cancers including Kaposi sarcoma, cervical cancer, and lymphoma in Malawi and South Africa
马拉维和南非的艾滋病毒癌症筛查和预后创新,包括卡波西肉瘤、宫颈癌和淋巴瘤
- 批准号:
10652369 - 财政年份:2020
- 资助金额:
$ 12.5万 - 项目类别:
An implementation science approach to address multi-level barriers to cancer screening among women living with HIV in South Africa
一种实施科学方法,以解决南非艾滋病毒感染妇女癌症筛查的多层次障碍
- 批准号:
10242935 - 财政年份:2020
- 资助金额:
$ 12.5万 - 项目类别:
Project 1: Urine sampling for HPV infection and methylation testing for cervical cancer screening among women living with HIV in Malawi and South Africa
项目 1:马拉维和南非艾滋病毒感染妇女的尿液采样以检测 HPV 感染,并进行甲基化检测以筛查宫颈癌
- 批准号:
10652392 - 财政年份:2020
- 资助金额:
$ 12.5万 - 项目类别:
Innovations for screening and prognosis in HIV+ cancers including Kaposi sarcoma, cervical cancer, and lymphoma in Malawi and South Africa
马拉维和南非的艾滋病毒癌症筛查和预后创新,包括卡波西肉瘤、宫颈癌和淋巴瘤
- 批准号:
10238155 - 财政年份:2020
- 资助金额:
$ 12.5万 - 项目类别:
Acceptability and feasibility of combination treatment for cervical precancer among South Africa women living with HIV
南非艾滋病毒感染者宫颈癌前病变联合治疗的可接受性和可行性
- 批准号:
10675732 - 财政年份:2020
- 资助金额:
$ 12.5万 - 项目类别:
Acceptability and feasibility of combination treatment for cervical precancer among South Africa women living with HIV
南非艾滋病毒感染者宫颈癌前病变联合治疗的可接受性和可行性
- 批准号:
10165676 - 财政年份:2020
- 资助金额:
$ 12.5万 - 项目类别:
Project 1: Urine sampling for HPV infection and methylation testing for cervical cancer screening among women living with HIV in Malawi and South Africa
项目 1:马拉维和南非艾滋病毒感染妇女的尿液采样以检测 HPV 感染,并进行甲基化检测以筛查宫颈癌
- 批准号:
10434863 - 财政年份:2020
- 资助金额:
$ 12.5万 - 项目类别:
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- 批准号:
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