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中癌症相关死亡率的主要原因 国家（LMIC）。世界卫生组织最近发布了认可替代方案的准则 基于细胞学的筛查，包括基于HPV的筛查和乙酸（VIA）的视觉检查，这 将有助于增加筛查覆盖范围并检测可治愈的宫颈癌前体。为了 减少宫颈癌的伯宁，必须将高效的筛查策略与负担得起 以及对预科病变的无障碍治疗。宫颈预科剂的标准处理，基于气体 冷冻疗法通常在LMIC中无法使用，因为汽油箱通常很昂贵，难以获得， 很难运输。随着筛选选项的增加，迫切需要一个 可以访问，便携和便宜的护理处理技术。我们感染了原始 热振子是一种现有的宫颈预科治疗装置，探针加热至100-120ºC，用于在 通过自定义LMIC的设备来大规模扩展，以满足这一需求。这个学术工业 合作伙伴关系将将这种新型设备与传统的基于CO2的冷冻疗法进行比较，以治疗宫颈 LMICS的前任者。该项目的具体目的是1）修改适用于适应的新型热能原型 并专门针对LMIC中的宫颈预科剂进行优化，确定更优化的患者 - 用于治疗高级预科剂的中心协议，证明了LMIC适应的效率 热耐药器不适合基于CO2的冷冻疗法，用于治疗宫颈预科剂，并确定 所有评估的治疗和治疗后监视策略的成本效益。假设是 测试的是，在临床有效性和成本 - 效力。研究小组与领先的地区组织建立了良好的关系 为政府举办的宫颈癌预防计划提供指导。 LMIC适应的部署 现有程序的热疗法不仅会提高程序效率，而且还将作为模型 在该地区采用该技术。这项研究的结果将通过作为 探索可容纳低资源设置的替代方案的跳板，因此 到达最脆弱的人群。