Comparison of cervical intraepithelial neoplasia 2/3 treatment outcomes with a portable LMIC-adapted thermal ablation device vs. gas-based cryotherapy
便携式 LMIC 热消融装置与气体冷冻疗法对宫颈上皮内瘤变 2/3 治疗结果的比较
基本信息
- 批准号:10488168
- 负责人:
- 金额:$ 63.19万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2018
- 资助国家:美国
- 起止时间:2018-01-12 至 2024-06-30
- 项目状态:已结题
- 来源:
- 关键词:Acetic AcidsAdoptedAdoptionAffectAftercareAreaBiopsyCancer EtiologyCarbon DioxideCervicalCervical Cancer ScreeningCervical Intraepithelial NeoplasiaCitiesClinicClinicalClinical ResearchClinical TrialsCoagulation ProcessCold TherapyCountryCustomCytologyDNADataDetectionDevelopmentDevicesDoseEngineeringEpidemiologistEvaluationExerciseGasesGeneral HospitalsGovernmentGuidelinesHealthHemorrhageHistologicHuman PapillomavirusLesionMalignant neoplasm of cervix uteriManualsMethodsMexicoMidwifeModelingNecrosisNurse MidwivesNursesPainPap smearPathologistPatientsPerformancePoint of Care TechnologyPower SourcesPredictive ValuePrevention programRandomizedRecurrenceResearchResource-limited settingRunningSensitivity and SpecificityStandardizationSterilizationSystemTechnologyTemperatureTestingTherapeuticThermal Ablation TherapyTimeTranslatingTreatment ProtocolsTreatment outcomeVisualVulnerable PopulationsWomanWorld Health Organizationalternative treatmentbasecancer preventioncervical cancer preventioncomparative cost effectivenesscost effectivenesseffective therapyimprovedindustry partnerinnovationlow and middle-income countriesmembermicrocostingmortalitynoveloff-label useoperationpatient orientedpoint of careportabilitypremalignantprogramsprototypescreeningscreening programsocialstandard caresurveillance strategyuser-friendly
项目摘要
Project Abstract
Cervical cancer is a leading cause of cancer-related mortality among women in low- and middle-income
countries (LMICs). The World Health Organization recently released guidelines that endorse alternatives to
cytology-based screening, including HPV-based screening and visual inspection with acetic acid (VIA), which
will facilitate increased screening coverage and detection of curable precursors to cervical cancer. In order to
reduce the burden of cervical cancer, highly effective screening strategies must be combined with affordable
and accessible treatment of precancerous lesions. The standard treatment for cervical precancer, gas-based
cryotherapy, is often not accessible in LMICs because gas tanks are generally expensive, difficult to obtain,
and hard to transport. With the number of screening options increasing, an urgent need exists for a point-of-
care treatment technology that is accessible, portable, and inexpensive. We innovated the original
thermoablator, an existing cervical precancer treatment device with a probe heated to 100-120º C, for use on a
wider scale by customizing the device for LMICs in order to meet this need. This academic-industrial
partnership will compare this novel device to traditional CO2-based cryotherapy for the treatment of cervical
precancer in LMICs. The Specific Aims of this project are to 1) modify a novel thermoablation prototype adapted
and optimized specifically for treatment of cervical precancer in LMICs, determine a more nearly optimal patient-
centered protocol for treatment of high-grade precancer, demonstrate that the efficacy of LMIC-adapted
thermoablator is non-inferior to CO2-based cryotherapy for the treatment of cervical precancer, and determine the
cost-effectiveness of all evaluated therapeutic and post-treatment surveillance strategies. The hypothesis being
tested is that this novel device is non-inferior to CO2-based cryotherapy in terms of clinical validity and cost-
effectiveness. The research team has well-established relationships with leading regional organizations that
provide guidance to government-run cervical cancer prevention programs. Deployment of the LMIC-adapted
thermoablator to existing programs will not only improve program efficacy, but will also serve as a model for
adoption of this technology in the region. The results of this study will affect other research areas by serving as
a springboard to exploring treatment alternatives that are amenable to low-resource settings and thus will
reach the most vulnerable populations.
项目摘要
宫颈癌是低收入和中等收入女性癌症相关死亡的主要原因
国家(中低收入国家)。世界卫生组织最近发布了支持替代品的指南
基于细胞学的筛查,包括基于 HPV 的筛查和醋酸目视检查 (VIA),
将有助于提高筛查覆盖率和检测可治愈的宫颈癌前兆。为了
减轻宫颈癌的负担,高效的筛查策略必须与负担得起的相结合
以及癌前病变的可及治疗。宫颈癌前病变的标准治疗以气体为主
冷冻疗法在中低收入国家通常无法获得,因为气罐通常价格昂贵且难以获得,
并且难以运输。随着筛查选项数量的增加,迫切需要一个点
护理治疗技术易于使用、便携且廉价。我们对原创进行了创新
Thermoablator,一种现有的宫颈癌前治疗设备,其探头加热至 100-120°C,用于
通过为中低收入国家定制器件来扩大规模,以满足这一需求。这个学术工业
合作伙伴关系将把这种新型设备与传统的基于二氧化碳的冷冻疗法进行比较,以治疗宫颈癌
中低收入国家的癌前病变。该项目的具体目标是 1) 修改一种新颖的热消融原型
并专门针对中低收入国家宫颈癌前病变的治疗进行优化,确定更接近最佳的患者-
以治疗高级别癌前病变为中心的方案,证明了 LMIC 适应的疗效
热消融仪治疗宫颈癌前病变的效果不逊色于基于 CO2 的冷冻疗法,并确定了
所有评估的治疗和治疗后监测策略的成本效益。假设是
经测试,这种新型设备在临床有效性和成本方面并不逊色于基于 CO2 的冷冻疗法。
效力。研究团队与领先的区域组织建立了良好的关系
为政府运行的宫颈癌预防计划提供指导。适应 LMIC 的部署
现有计划的热消融术不仅会提高计划的功效,而且还将作为一个模型
该技术在该地区的采用。这项研究的结果将影响其他研究领域
探索适合资源匮乏环境的治疗替代方案的跳板,从而将
惠及最弱势群体。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Miriam Cremer其他文献
Miriam Cremer的其他文献
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{{ truncateString('Miriam Cremer', 18)}}的其他基金
Development of an HPV stigma assessment scale and a stigma-reducing intervention to improve cervical cancer prevention in El Salvador
制定 HPV 耻辱评估量表和减少耻辱干预措施,以改善萨尔瓦多的宫颈癌预防
- 批准号:
10844859 - 财政年份:2023
- 资助金额:
$ 63.19万 - 项目类别:
Single Visit Clinical Validation of ScreenFire, a Low-Cost HPV Test: Efficacy and Cost Effectiveness (SCALE)
ScreenFire(一种低成本 HPV 检测)的单次临床验证:功效和成本效益 (SCALE)
- 批准号:
10595668 - 财政年份:2022
- 资助金额:
$ 63.19万 - 项目类别:
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:
10696230 - 财政年份:2022
- 资助金额:
$ 63.19万 - 项目类别:
Single Visit Clinical Validation of ScreenFire, a Low-Cost HPV Test: Efficacy and Cost Effectiveness (SCALE)
ScreenFire(一种低成本 HPV 检测)的单次临床验证:功效和成本效益 (SCALE)
- 批准号:
10340927 - 财政年份:2022
- 资助金额:
$ 63.19万 - 项目类别:
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 - 财政年份:2022
- 资助金额:
$ 63.19万 - 项目类别:
Comparison of cervical intraepithelial neoplasia 2/3 treatment outcomes with a portable LMIC-adapted thermal ablation device vs. gas-based cryotherapy
便携式 LMIC 热消融装置与气体冷冻疗法对宫颈上皮内瘤变 2/3 治疗结果的比较
- 批准号:
10662503 - 财政年份:2018
- 资助金额:
$ 63.19万 - 项目类别:
Comparison of cervical intraepithelial neoplasia 2/3 treatment outcomes with a portable LMIC-adapted thermal ablation device vs. gas-based cryotherapy
便携式 LMIC 热消融装置与气体冷冻疗法对宫颈上皮内瘤变 2/3 治疗结果的比较
- 批准号:
10411389 - 财政年份:2018
- 资助金额:
$ 63.19万 - 项目类别:
Development of an LMIC-adapted Thermocoagulation Prototype for the Treatment of Cervical Pre-cancer.
开发适合 LMIC 的热凝原型,用于治疗宫颈癌前病变。
- 批准号:
9903657 - 财政年份:2018
- 资助金额:
$ 63.19万 - 项目类别:
CryoPen: An Innovative Treatment for Cervical Precancer in Low-Resource Setting
CryoPen:资源匮乏环境下宫颈癌前病变的创新治疗方法
- 批准号:
9355105 - 财政年份:2015
- 资助金额:
$ 63.19万 - 项目类别:
CryoPen: An Innovative Treatment for Cervical Precancer in Low-Resource Setting
CryoPen:资源匮乏环境下宫颈癌前病变的创新治疗方法
- 批准号:
8930106 - 财政年份:2015
- 资助金额:
$ 63.19万 - 项目类别:
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