A Viable Solution for a See and Treat Paradigm for Cervical Pre-cancer in Africa

非洲宫颈癌前病变“即见即治”模式的可行解决方案

• 批准号: 9302705
• 负责人: Nirmala Ramanujam
• 金额: $ 20.22万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-01 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9302705
• 关键词: Academic Medical Centers; Acetic Acids; Acids; Adoption; Affect; Africa; Algorithms; Biopsy; Biopsy Specimen; Calibration; Capital; Care Technology Points; Caring; Cervical; Cervical Cancer Screening; Cervical dysplasia; Cervix Neoplasms; Cervix Uteri; Cessation of life; Clinic; Clinical; Clinical Research; Cold Therapy; Collaborations; Colposcopes; Colposcopy; Columnar Epithelium; Communities; Consumption; Country; Data; Devices; Diagnosis; Diffuse; Disease; Early Diagnosis; Early treatment; Ensure; Eye; Goals; Gold; Guidelines; Hand; Health; Hemoglobin; Histopathology; Hospitals; Human Papillomavirus; Human Resources; Image; Incidence; Income; Lesion; Link; Loop electrosurgical excision procedure; Maintenance; Malignant neoplasm of cervix uteri; Measurement; Measures; Medical center; Methods; Microscope; Modeling; Morphology; Optics; Oxygen; Pap smear; Pathologist; Pathology; Patients; Performance; Persons; Phase; Physicians; Physiology; Pilot Projects; Premalignant; Primary Health Care; Procedures; Public Health; Qualitative Methods; Recording of previous events; Regulation; Reproducibility; Research; Research Infrastructure; Resources; Sensitivity and Specificity; Site; Specificity; Spectrum Analysis; Spottings; Stratification; Stratified Squamous Epithelium; System; Tanzania; Technology; Testing; Time; Tissues; Training; Visible Radiation; Vision; Visit; Visual; Woman; absorption; arm; base; cervical cancer prevention; clinical investigation; cost; density; digital; experience; global health; improved; in vivo; low and middle-income countries; mortality; neovascularization; portability; pressure; public health relevance; screening; sensor; spectroscopic data; standard of care; success; temporal measurement; tumor progression

 DESCRIPTION (provided by applicant): There is a critical global need for a See and Treat paradigm for cervical cancer that is effective in low-and middle-income communities (LMIC). Guidelines have been written by the Alliance for Cervical Cancer Prevention (ACCP) on strategies for screening cervical cancer in resource-limited settings. Visual inspection with aceti acid (VIA) or VIA with low power magnification (VIAM) combined with cryotherapy or Loop Electrosurgical Procedure (LEEP) appears to be the most viable option for reducing the mortality associated with cervical cancer in the low and middle income countries (LMICs). The colposcope, a low magnification microscope has been historically used for (VIAM) in women with an abnormal Pap smear. Sites that display acetowhitening are biopsied and evaluated by a pathologist. The cervix is treated with LEEP if pre-cancerous lesions are found. In LMICs, this approach is not practical due to the lack of infrastructure and resources and also due to patient attrition at each level of care. Thus it is critical to develop point of care technologies that enale a see and treat paradigm in a single visit within the local communities where the women live. Our long-term goal is to leverage community-clinics as a way to bring early detection and treatment of cervical pre-cancer to as many patients as possible in LMICs particularly in places where hospitals are not easily accessible. We propose to implement a portable, point of care technology that consolidates the colposcope into a hand-held device and with an integrated visible light diffuse reflectance optical spectroscope that rapidly measures oxygen saturation, neovascularization and the morphological composition of acetowhitened sites identified by VIAM that are known to be altered with neoplastic progressions. The colpospectroscope will enable surveillance with VIAM followed by spectroscopy (in lieu histopathology on a biopsy specimen) such that cervical dysplasia can be diagnosed "on the spot" thereby enabling a see and treat paradigm for women with cervical pre-cancer with cryotherapy and/or LEEP in at the same visit.

 描述(由申请人提供)：全球迫切需要一种在低收入和中等收入社区(LMIC)有效的宫颈癌SEE和治疗范例。宫颈癌预防联盟(ACCP)已经编写了关于在资源有限的情况下筛查宫颈癌的战略的指南。在中低收入国家(LMIC)，用醋酸(VIA)或低倍放大率(VIAM)进行目视检查，结合冷冻或环状电外科(LEEP)似乎是降低宫颈癌相关死亡率的最可行的选择。镜是一种低倍显微镜，历史上曾用于巴氏涂片异常的女性的VIAM检查。出现乙酰白化的部位由病理学家进行活组织检查和评估。如果发现癌前病变，就用LEEP治疗宫颈。在LMIC中，由于缺乏基础设施和资源，以及每个护理级别的患者自然流失，这种方法是不可行的。因此，至关重要的是开发护理点技术，在妇女所在的当地社区内实现一次就诊即可看到和治疗的范例。我们的长期目标是利用社区诊所作为一种方式，使尽可能多的LMIC患者及早发现和治疗宫颈癌前病变，特别是在医院不容易到达的地方。我们建议实施一种便携式护理点技术，将镜整合到手持设备中，并使用集成的可见光漫反射光学分光镜快速测量血氧饱和度、新生血管和VIAM确定的乙酰白化部位的形态组成，这些部位已知会随着肿瘤的进展而改变。镜将能够使用VIAM进行监测，然后进行光谱学检查(代替活检标本的组织病理学检查)，这样可以“现场”诊断宫颈异型增生，从而使冷冻和/或LEEP同时进行的宫颈癌前病变妇女的SEE和治疗模式成为可能。