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: 10488168
• 负责人: Miriam Cremer
• 金额: $ 63.19万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 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: https://reporter.nih.gov/project-details/10488168
• 关键词: Acetic Acids; Adopted; Adoption; Affect; Aftercare; Area; Biopsy; Cancer Etiology; Carbon Dioxide; Cervical; Cervical Cancer Screening; Cervical Intraepithelial Neoplasia; Cities; Clinic; Clinical; Clinical Research; Clinical Trials; Coagulation Process; Cold Therapy; Country; Custom; Cytology; DNA; Data; Detection; Development; Devices; Dose; Engineering; Epidemiologist; Evaluation; Exercise; Gases; General Hospitals; Government; Guidelines; Health; Hemorrhage; Histologic; Human Papillomavirus; Lesion; Malignant neoplasm of cervix uteri; Manuals; Methods; Mexico; Midwife; Modeling; Necrosis; Nurse Midwives; Nurses; Pain; Pap smear; Pathologist; Patients; Performance; Point of Care Technology; Power Sources; Predictive Value; Prevention program; Randomized; Recurrence; Research; Resource-limited setting; Running; Sensitivity and Specificity; Standardization; Sterilization; System; Technology; Temperature; Testing; Therapeutic; Thermal Ablation Therapy; Time; Translating; Treatment Protocols; Treatment outcome; Visual; Vulnerable Populations; Woman; World Health Organization; alternative treatment; base; cancer prevention; cervical cancer prevention; comparative cost effectiveness; cost effectiveness; effective therapy; improved; industry partner; innovation; low and middle-income countries; member; microcosting; mortality; novel; off-label use; operation; patient oriented; point of care; portability; premalignant; programs; prototype; screening; screening program; social; standard care; surveillance strategy; user-friendly

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。