Novel see and treat strategies for cervical cancer prevention in low-resource settings

在资源匮乏地区预防宫颈癌的新颖的观察和治疗策略

• 批准号: 9753417
• 负责人: DAVID Frank KATZ
• 金额: $ 62.11万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-02-01 至 2024-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9753417
• 关键词: Ablation; Academic Medical Centers; Acetic Acids; Address; Algorithms; Archives; Biopsy; Blinded; Blood Vessels; Cardiomyopathies; Caring; Cause of Death; Cellulose; Cervical; Cervical Cancer Screening; Cervix Uteri; Cessation of life; Clinic; Clinical; Clinical Research; Cold Therapy; Colposcopes; Colposcopy; Communities; Contrast Media; Country; Coupled; Decision Making; Detection; Devices; Diagnosis; Diagnostic; Disease; Disinfection; Electrocoagulation; Ensure; Environment; Ethanol; Excision; Exposure to; Family suidae; Fluorescein; Food Additives; Funding; Gel; Goals; Gold; Health Resources; Health care facility; Human; Image; Imagery; Income; Injections; Intervention; Iodine; Lesion; Lighting; Local Therapy; Loop electrosurgical excision procedure; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Methods; Microscope; Microscopic; Modeling; Output; Pap smear; Pathology; Patients; Physicians; Procedures; Process; Protocols documentation; Provider; Public Health; Quality Control; Research; Resources; Safety; Screening Result; Sensitivity and Specificity; Silicones; Site; Solid Neoplasm; Source; Speculums; Stains; Systemic Therapy; Technology; Testing; Therapeutic; Therapeutic Agents; Tissues; Treatment Efficacy; Vagina; Vision; Water; Woman; Work; aqueous; base; cervical cancer prevention; clinical Diagnosis; clinical development; contrast enhanced; cost; design; experience; image visualization; improved; in vivo; innovation; intervention cost; low and middle-income countries; medically underserved; mortality; novel; portability; preference; screening; tv watching; user-friendly; volunteer

Cervical cancer is the second leading cause of death for women worldwide; 85% of deaths occur in low and middle- income countries (LMICs), despite the fact that well-established interventions exist for pre-invasive disease. In the U.S., screening for cervical cancer is performed with the Papanicolaou (Pap) smear. Colposcopy, which visualizes the acetic acid stained cervix with a low power microscope, followed by biopsy of cervical abnormalities, serves as a confirmatory test for women with positive screening results. Women with pre-cancer are treated via excision of a portion of the cervix using Loop Electrosurgical Excision Procedure (LEEP). Women with cancer are referred to a combination of local and/or systemic therapy depending on the stage of invasive disease. This model is not practical to implement in medically-underserved regions due to lack of resources to procure, implement, and maintain the technologies in the care cascade. Thus, alternative protocols that employ low-cost, simple-to-use technologies are needed to mitigate cervical cancer. Our vision is to develop high quality, low-cost interventions that will be effective in low-resource health facilities to address shortcomings of current technological solutions to cervical cancer prevention. This vision requires 3 distinct innovations: 1) an ultra-portable visualization device coupled with routinely used contrast agents to reduce discomfort, enable visualization of microscopic disease, and provide quality control through image review and archiving (Aim 1); 2) enhanced contrast and smart algorithms to reduce unnecessary referrals or treatment of screen positive women (in the absence of confirmatory biopsy) (Aim 2); and 3) a low-cost therapeutic that is as effective as current ablative approaches but more readily accessible to treat pre-invasive disease (Aim 3). These innovations build upon: 1) a novel Pocket colposcope developed under previous funding that enables portable colposcopy of the cervix; and 2) preliminary results that support these new innovations.

宫颈癌是全球女性死亡的第二大原因; 85%的死亡发生在低危和中危人群中- 低收入国家（LMIC），尽管事实上存在针对侵袭前疾病的完善干预措施。在 美国，子宫颈癌的筛查是通过巴氏涂片进行的。阴道镜检查， 用低倍显微镜对宫颈进行醋酸染色，然后对宫颈异常进行活检， 对筛查结果呈阳性的妇女进行确证测试。患有癌症前期的妇女通过切除 使用环形电外科切除术（LEEP）切除宫颈部分。患有癌症的妇女被转介到 根据侵袭性疾病的阶段，局部和/或全身治疗的组合。这种模式不实用 在医疗服务不足的地区实施，因为缺乏资源来采购，实施和维护 护理级联中的技术。因此，采用低成本、易于使用的技术的替代协议是 来缓解宫颈癌。我们的愿景是开发高质量、低成本的干预措施， 资源匮乏的卫生设施，以解决目前预防宫颈癌技术解决方案的不足。 这一愿景需要3个不同的创新：1）超便携式可视化设备加上常规使用的对比度 减少不适，使微观疾病可视化，并通过图像提供质量控制的试剂 审查和存档（目标1）; 2）增强对比度和智能算法，以减少不必要的转诊或治疗 的筛查阳性妇女（在没有确证性活检的情况下）（目标2）;和3）低成本的治疗， 与目前的消融方法一样有效，但更容易治疗浸润前疾病（目标3）。这些 创新建立在：1）在以前的资助下开发的新型袖珍阴道镜， 宫颈阴道镜检查; 2）支持这些新创新的初步结果。