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
本申请是为了响应被标识为NOT-CA的特别利益通知(NOSI)而提交的-
22-036.浸润性宫颈癌(ICC)仍然是两个国家弱势群体的公共卫生问题。
1每年,全世界约有342,000人死于ICC,
85%的死亡发生在中低收入国家。1 ICC可通过人乳头瘤病毒(HPV)疫苗接种预防,
筛查和治疗宫颈上皮内瘤变2或更高(CIN 2+)。2然而,获得这些
国际刑事法院预防战略仍然有限,特别是在中低收入国家,在撒哈拉以南非洲更是如此
由于感染艾滋病毒的妇女(WLWH)持续感染HPV的风险增加,
上皮内瘤变2级或更高(CIN 2+),ICC。3 -5马拉维是撒哈拉以南非洲国家,拥有世界上最高的ICC。
6在15-49岁的女性中,艾滋病毒感染率为11%,
39%的妇女在WLWH.8 2019年,马拉维启动了一项针对青春期女孩的国家HPV疫苗接种计划,
9,10然而,在不久的将来,大多数马拉维妇女将没有资格接种疫苗
因为他们的年龄,因此将保持未接种疫苗。即使青少年普遍接种HPV疫苗,
尽管如此,预计ICC死亡率在几十年内不会随之下降。
快速HPV检测引起了人们的兴趣,因为它允许当天筛查和治疗ICC预防策略。
AmpFire® HPV基因分型系统是由Atila开发的独特核酸扩增技术
biosystems公司它使用一种低成本的便携式仪器,
HPV检测结果在大约一个小时,可用于干拭子。因此,hrHPV基因分型相同-
AmpFire®可在中低收入国家实施为期一天的HPV筛查和治疗计划。为此,补充
研究项目,我们计划评估不同样本类型的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基因型具有最高的
在马拉维利隆圭的627个WLWH中,331个hrHPV+的子集对CIN 2+的敏感性。这些
我们的U 54资助的研究(U 54 CA 254564)已经招募了女性,并对其进行了随访,该研究评估了
另一种潜在的分诊测试S5甲基化的性能,用于检测WLWH中的CIN 2+。
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,
收集的宫颈阴道和提供者收集的宫颈样本,用于检测不同的高危
WLWH中的HPV基因型。目的2:探索尿液中检测到的hrHPV基因型,
自我收集的宫颈阴道和提供者收集的宫颈样本对
检测CIN 2+。目的3:探讨在自行采集的尿液中检出的hrHPV基因型
宫颈阴道和提供者收集的宫颈样本与热消融治疗相关
失败
项目成果
期刊论文数量(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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