Early Stage Diagnosis of Kaposi's Sarcoma in Limited Resource Settings using KS-Detect

使用 KS-Detect 在有限资源环境下对卡波西肉瘤进行早期诊断

• 批准号: 10018466
• 负责人: David Carl Erickson
• 金额: $ 90.68万
• 依托单位: CORNELL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-17 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10018466
• 关键词: Africa; Africa South of the Sahara; African; Area; Biological Assay; Biopsy; Businesses; CD4 Lymphocyte Count; Cellular Phone; Clinic; Clinical; Communicable Diseases; Communities; Data Analyses; Dermatology; Detection; Development; Diagnosis; Diagnostic; Diagnostic Procedure; Diagnostic tests; Disease; Early Diagnosis; Engineering; Epidemiologist; Epidemiology; Feedback; Goals; Health; Health Sciences; Health Technology; Heating; Histologic; Hospitals; Human Herpesvirus 8; Image; Immunohistochemistry; Infrastructure; Institutes; Kaposi Sarcoma; Kenya; Lead; Light; Lighting; Malignant Neoplasms; Methods; Nucleic Acids; Oncology; Outcome; Pathologist; Pathology; Phase; Physicians; Procedures; Resources; Running; Sampling; San Francisco; Serologic tests; Seroprevalences; Services; Site; Skin; System; Technology; Testing; Time; Training; Translations; Uganda; Universities; Validation; Viral; Virus; Woman; base; chemotherapy; commercialization; cost; field study; global health; improved; low and middle-income countries; medical schools; men; molecular pathology; operation; point of care; point-of-care diagnostics; preclinical trial; prevent; product development; professor; prototype; public health relevance; rapid detection; rapid diagnosis; repaired; sample collection; tumor; usability

 DESCRIPTION (provided by applicant): In this project, we will field-test and clinically validate a rapid, point-of-care platform for the diagnosis of Kaposi's sarcoma (KS) in limited resource settings. Our "KS-Detect" diagnostic platform uses solar- power and smartphone technology enabling it to be operated without reliance on any external infrastructure, while maintaining a high degree of usability with low per-unit cost. The ability to provide rapid confirmatory diagnosi of KS promises to facilitate earlier detection of KS in the community at a clinical stage when it i more responsive to therapy. Specific diagnosis of KS also prevents inappropriate therapy of clinical mimickers of KS. By the end of the project, we will have demonstrated both the field efficacy of the diagnostic technology as well as quantifiably evaluated its effect on promoting earlier detection of KS. To achieve this, we have brought together a team of engineers, local physicians, clinical epidemiologists, business people, translation partners, and entrepreneurs from Cornell, UC-San Francisco and the Infectious Diseases Institute in Kampala, Uganda. Prof. David Erickson (Contact- PI, Cornell), an engineer and entrepreneur from Cornell University, is the original developer of the KS- Detect technology and will lead the engineering and product development efforts while Prof. Jeff Martin (PI, UCSF), a KS epidemiologist and Prof. Toby Maurer (UCSF), a clinician, will lead the clinical and deployment efforts along with our partners in Uganda. Dr. Ethel Cesarman (Weill Cornell) as one of the original discoverers of the virus that causes KS, will lead the local molecular pathology effort. With our translation partner, A'As inc., we will develop a dual-use platform that can be powered by either direct solar heating, solar panels, or conventional electrical outlet to enable both field and lab operation without changing the analysis method. In Phase I of this project, we will (1) collect 500 samples from our Ugandan partner site and validate the PCR based assay; (2) construct a set of field ruggedized dual use KS-Detect systems and consumables; and (3) deploy 5 units for 3 months with local health technicians. If successful, in Phase II we will perform an extensive field study deploying 17 KS-Detect units in Uganda, operated and serviced by locally trained clinicians, and demonstrate the ability of the system to enable earlier stage detection of KS than existing diagnostic procedures.

 描述（由申请人提供）：在这个项目中，我们将现场测试和临床验证一个快速，即时护理平台，用于在有限的资源环境中诊断卡波西肉瘤（KS）。我们的“KS-Detect”诊断平台使用太阳能及智能手机技术，使其无需依赖任何外部基础设施即可操作，同时以较低的单位成本保持高度可用性。提供KS的快速确认诊断的能力有望促进在社区中在临床阶段早期检测KS，此时其对治疗更敏感。KS的特异性诊断还可防止KS临床模仿者的不适当治疗。到项目结束时，我们将证明诊断技术的现场有效性，并定量评估其对促进KS早期检测的效果。为了实现这一目标，我们汇集了来自康奈尔大学、加州大学旧金山分校弗朗西斯科分校和乌干达坎帕拉传染病研究所的工程师、当地医生、临床流行病学家、商界人士、翻译合作伙伴和企业家。来自康奈尔大学的工程师和企业家大卫埃里克森教授（康奈尔大学PI）是KS- Detect技术的原始开发者，将领导工程和产品开发工作，而KS流行病学家杰夫马丁教授（加州大学旧金山分校PI）和临床医生托比毛雷尔教授（加州大学旧金山分校）将与我们在乌干达的合作伙伴一起沿着领导临床和部署工作。Ethel Cesarman博士（Weill Cornell）作为导致KS的病毒的最初发现者之一，将领导当地的分子病理学工作。与我们的翻译合作伙伴A 'As inc. 我们将开发一个两用平台，可以通过直接太阳能加热、太阳能电池板或传统电源插座供电，从而在不改变分析方法的情况下实现现场和实验室操作。在该项目的第一阶段，我们将（1）从我们的乌干达合作伙伴现场收集500份样本，并验证基于PCR的检测方法;（2）构建一套现场加固型两用KS-Detect系统和耗材;以及（3）与当地卫生技术人员一起部署5台设备，为期3个月。如果成功的话，在第二阶段，我们将在乌干达部署17个KS-Detect单元进行广泛的实地研究，由当地训练有素的临床医生操作和服务，并证明该系统能够比现有的诊断程序更早地检测KS。