Automatic Detection of Critical Dermoscopy Features for Basal Cell Carcinoma

描述(申请人提供)：SkinScan数字皮肤镜皮肤癌检测软件，由密苏里州的S&A公司开发，现在可以检测早期黑色素瘤的关键特征。然而，另外90%以上的皮肤癌也需要诊断帮助。在皮肤癌筛查方面的诊断改进的需求可能在那些护士从业人员中最大，他们现在在一些服务不足的地区为大多数老年患者看病。服务不足的临床领域皮肤癌发病率高于平均水平，大量护士执业，包括S&A所在的中西部农村地区的民用和军事诊所。这款创新的软件是一个及时的开发，旨在解决每个医疗保健消费者遇到的问题-获得特殊护理的等待时间太长，获得护理时诊断的不确定性，以及提供护理的总体支出太大。拟议的第一阶段研究涉及开发用于基底细胞癌的SkinScan自动检测模块所需的步骤。由Stoecker和Stolz最先描述的基本功能将在第一阶段进行编程，并纳入我们的早期检测系统。第一阶段的额外工作将允许获取更多的临床和皮肤镜图像，将允许培训第一名护士从业者，并将允许开发用于诊断基底细胞癌的分级神经网络。经过十多年的开发，使用了美国和欧洲皮肤科实践的数千张图像，SkinScan将在第二阶段研究期结束时在早期癌症检测临床试验中证明有效。这项试验为产品提供了一座进入市场的桥梁，该产品将通过检测这些皮肤癌的关键早期特征，为最致命的皮肤癌、黑色素瘤和最常见的皮肤癌(基底细胞癌)提供自动化诊断辅助，从而增加获得高质量护理的机会。该软件旨在指导非专科护士或医生助理，帮助做出活组织检查/不活组织检查的决定，这是早期发现皮肤癌的最关键决定。 公共卫生相关性：S&A提出皮肤癌筛查皮肤扫描培训系统，以满足护士从业人员发现皮肤癌的需求。S为从业者提供了一个集成的数据库系统，即使是那些没有接受过皮肤病专业培训的人，也可以在皮肤癌变得致命之前，在非常早期的阶段识别出皮肤癌。S&A皮肤扫描培训系统由3部分组成：带可搜索图谱的皮肤镜癌症检测软件、DermLite D3交叉偏振光皮肤镜和黑色素瘤与模拟临床教程。这项研究计划的第一阶段包含开发最先进的软件的关键里程碑，该软件专门用于在皮肤镜图像上识别最常见的皮肤癌--基底细胞癌--的迹象。SkinScan在市场竞争中处于非常有利的地位。S&A的关键人员拥有数十年的软件开发经验和将创新软件引入皮肤科市场的记录。SkinScan系统是第一款面向执业护士、医生助理和家庭从业人员销售的此类产品。这项建议集中在护士从业人员，这是最大的非医生从业者群体，主要是在全科医生环境中看到的成年人。这项提案的第一阶段和第二阶段应允许我们进入软件销售阶段。之后，与战略合作伙伴的整合将允许市场扩张。

DESCRIPTION (provided by applicant): SkinScan digital dermoscopy skin cancer detection software, developed by Missouri's S&A, can now detect critical features of early melanoma. However, there is also a need for diagnostic help for the other 90+% of skin cancers. The need for diagnostic improvement in screening for skin cancers may be greatest in those nurse practitioners who now see the majority of elderly patients in some underserved areas. Underserved clinical arenas with a greater than average incidence of skin cancer and significant numbers of nurse practitioners include both civilian and military clinics in the rural Midwest, where S&A is located. This innovative software is a timely development designed to solve problems every healthcare consumer has encountered- too long a wait to get specialty care, uncertainty about the diagnosis when one does get the care, and too much overall expenditure in providing the care. The proposed Phase I research addresses the steps needed to develop the SkinScan automatic detection modules for basal cell carcinoma. The BASAL features, first described by Stoecker and Stolz, will be programmed during Phase I and incorporated in our early detection system. Additional work during Phase I will allow acquisition of more clinical and dermoscopy images, will allow training of the first nurse practitioner, and will allow development of a hierarchical neural network for diagnosis of basal cell carcinoma. With over a decade of development using thousands of images from dermatology practices in the United States and Europe, SkinScan at the end of the Phase II research period will have demonstrated effectiveness in an early cancer detection clinical trial. This trial provides a bridge to market for a product that will result in increased access to high quality care by providing automated diagnostic assistance for the most deadly skin cancer, melanoma, and the most common skin cancer, basal cell carcinoma, by detecting key early features of these skin cancers. The software is designed to guide the non-specialist nurse practitioner or physician assistant, helping to make the biopsy/no biopsy decision, the most critical decision in early detection of skin cancer. PUBLIC HEALTH RELEVANCE: S&A proposes the SkinScan Training System for Skin Cancer Screening, to meet the needs of nurse practitioners in finding skin cancers. S&A offers practitioners an integrated database system that allows even those without specialized dermatology training to identify skin cancers at a very early stage, before they become deadly. The S&A SkinScan Training System is comprised of 3 parts: Dermoscopy cancer detection software with searchable atlas, DermLite D3 cross-polarized light dermoscope, and Melanoma and Mimics Clinical Tutorial. Phase I of this research proposal contains key milestones in development of the most advanced software dedicated to identifying signs on dermoscopy images of the most common skin cancer, basal cell carcinoma. SkinScan is in an excellent position to compete in the marketplace. Key personnel at S&A bring decades of experience in software development and a record of introducing innovative software to the dermatology market. The SkinScan system is the first such product to be marketed to nurse practitioners, physician assistants, and family practitioners. This proposal concentrates on nurse practitioners, the largest single group of non-physician practitioners seeing primarily adults in a general practice setting. Phase I and Phase II of this proposal should allow us to reach the software sale stage. After that, integration with strategic partners will allow market expansion.