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