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: 8882726
• 负责人: Nirmala Ramanujam
• 金额: $ 21.89万
• 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/8882726
• 关键词: Academic Medical Centers; Acetic Acids; Acids; Adoption; Affect; Africa; Algorithms; Biopsy; Biopsy Specimen; Calibration; Cancerous; 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; Life; Link; Loop electrosurgical excision procedure; Maintenance; Malignant Neoplasms; 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; Primary Health Care; Procedures; Public Health; Qualitative Methods; Recording of previous events; Regulation; Relative (related person); Research; Research Infrastructure; Resources; Sensitivity and Specificity; Site; Solutions; Specificity; Spectrum Analysis; Spottings; Stratification; Stratified Squamous Epithelium; System; Tanzania; Technology; Testing; Time; Tissues; Training; Visible Radiation; Vision; Visit; Visual; Woman; Writing; absorption; arm; base; cervical cancer prevention; clinical investigation; cost; density; digital; experience; global health; improved; in vivo; mortality; neovascularization; pressure; public health relevance; screening; sensor; spectroscopic imaging; 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）：全球迫切需要在低收入和中等收入社区（LMIC）有效的宫颈癌“看和治疗”模式。宫颈癌预防联盟编写了关于在资源有限的情况下筛查宫颈癌的战略指南。在低收入和中等收入国家（LMIC），使用醋酸（VIA）或低倍放大率VIA（VIAM）结合冷冻疗法或环形电外科手术（LEEP）进行目视检查似乎是降低宫颈癌相关死亡率的最可行选择。阴道镜是一种低放大率的显微镜，历史上曾用于（VIAM）巴氏涂片异常的妇女。由病理学家对显示醋酸增白的部位进行活检和评估。如果发现癌前病变，则采用LEEP治疗宫颈。在中低收入国家，由于缺乏基础设施和资源，以及各级护理的患者流失，这种方法并不实用。因此，关键是要开发护理点技术，在妇女居住的当地社区内进行一次访问，就能实现“看和治疗”模式。 我们的长期目标是利用社区诊所作为一种方式，为中低收入国家，特别是在医院不容易到达的地方，尽可能多的患者提供宫颈癌前期的早期检测和治疗。我们建议实施一种便携式护理点技术，该技术将阴道镜整合到手持式设备中，并具有集成的可见光漫反射光谱仪，该光谱仪可快速测量血氧饱和度、新血管形成和通过VIAM识别的乙酰白化部位的形态组成，这些部位已知会随着肿瘤进展而改变。阴道镜将能够通过VIAM进行监测，然后通过光谱学（代替活检标本上的组织病理学）进行监测，从而可以“当场”诊断宫颈发育不良，从而能够在同一次访视中为患有宫颈癌前病变的女性提供冷冻疗法和/或LEEP的观察和治疗范例。