Diagnosis of Cervical Precancers Using Raman Spectroscopy

描述（由申请人提供）：宫颈癌是全球女性中第二常见的恶性肿瘤。据估计，2007年，仅在美国就将有3 670人死于这种疾病，并将诊断出11 150例新的浸润性宫颈癌病例。尽管在过去的50年里，宫颈癌前病变的早期发现在降低与这种疾病相关的死亡率方面发挥了重要作用，但宫颈浸润前鳞状细胞癌的发病率仍然很低。如果宫颈癌被早期发现，它们是高度可治愈的。现有的筛查和检测技术，巴氏涂片和阴道镜检查，有几个缺陷，防止有效的管理，否则可控的疾病。一种具有改进的灵敏度和特异性的自动诊断方法，可以允许"看和治疗"方案，将显著改善疾病的管理。该提案试图证明以下假设：拉曼光谱可以提供宫颈癌前病变的鉴别诊断，高级别和低级别的宫颈癌前病变与宫颈的炎症、鳞状上皮化生和正常区域。该提案的主要目的是表征和验证低级别病变可以与高级别病变以及正常宫颈区分，并且无论患者的绝经状态如何都可以进行该诊断。这将通过进行大规模临床研究、从正常和疾病子宫颈收集拉曼光谱、通过组织学类别将其分离并通过多类别鉴别算法将其分类来实现。此外，随着组织光谱特征的独特模型的开发，我们试图使用该模型来理解疾病过程，因为它适用于光谱学。最后，系统将更新为尽可能紧凑，软件开发为"简单"（一键收集和光谱分类），以供临床使用。拟议工作的结果将对卫生保健产生重大影响，通过单一检测工具提供全面疾病管理的潜力。这将改善患者护理和成本效益。随着这项技术的成功，拉曼光谱可以应用于其他器官部位，如前列腺和卵巢以及其他疾病，从而影响更广泛的医学领域。公共卫生相关性：宫颈癌是全球妇女中第二大常见癌症。早期发现宫颈癌前病变是在其变成癌症之前进行适当治疗的关键。目前使用的检测宫颈癌前病变的方法在从其他非正常状况中识别低级别和高级别疾病的能力方面是有限的。该提案提出了一种用于真实的时间检测宫颈癌前病变以指导治疗的方法。拉曼光谱有可能成为一种更准确和更便宜的筛查和诊断宫颈发育不良的方法。拉曼光谱能够实现"看和治疗"方案的能力将减少复诊次数和患者焦虑，因为组织病理学诊断的长时间等待将被消除。因此，该技术有可能增加对服务不足的人群的访问，这些人群可能无法进行筛查。该技术对患者没有已知的风险，因此可能是当前筛查方法的安全替代方案。

DESCRIPTION (provided by applicant): Cervical cancer is the second most common malignancy among women worldwide. It is estimated that in 2007, 3,670 deaths will occur in the United States alone from this disease and 11,150 new cases of invasive cervical cancer will be diagnosed. Although early detection of cervical precancer has played a central role in reducing the mortality associated with this disease over the last 50 years, the incidence of pre-invasive squamous carcinoma of the cervix. When cervical cancers are detected early, they are highly curable. Existing screening and detection techniques, the Pap smear and colposcopy, have several deficiencies that prevent efficient management of an otherwise controllable disease. An automated diagnostic method with improved sensitivity and specificity that could allow for a "See and Treat" protocol would significantly improve the management of the disease. This proposal seeks to prove the hypothesis that Raman spectroscopy, can provide differential diagnosis of cervical precancers, both high and low grade from inflammation, squamous metaplasia and normal areas of the cervix. The main objective of this proposal is to characterize and validate that low grade lesions can be differentiate from high grade lesions as well as the normal cervix and that this diagnosis can be performed regardless of the menopausal status of the patient. This will be accomplished by conducting a large clinical investigation, collecting Raman spectra from both normal and diseases cervix, separating them by histological category and classifying them via a multi-class discrimination algorithm. Additionally, with the development of a unique model for tissue spectral signatures, we seek to use this model to understand the disease process as it applies to optical spectroscopy. Finally, the system will be updated to be as compact as possible and the software developed to be "easy" (one click collection and classification of a spectra) for clinical use. The results of the proposed work will have a significant impact on health care by providing the potential for complete disease management with a single detection tool. This would result in improved patient care and cost-effectiveness. With the success of this technique, Raman spectroscopy can be applied to other organ sites such as the prostate and ovary as well as other diseases thus impacting a broader field in medicine. PUBLIC HEALTH RELEVANCE: Cervical cancer is the second most common type of cancer among women worldwide. Early detection of cervical precancer is the key to proper treatment of the disease before it becomes a cancer. Methods of detecting cervical precancer used today are limited in their ability to identify low and high grade disease from other non-normal conditions. This proposal presents a method for detecting cervical precancers in real time to guide treatment. Raman spectroscopy has the potential to be a more accurate and less expensive method of screening and diagnosing cervical dysplasia. The ability of Raman spectroscopy to enable a "see and treat" protocol would decrease the number of return clinic visits and patient anxiety as the long waits for histopathology diagnoses would be eliminated. Thus, the technology has the potential to increase access to underserved populations where follow-up to screening may not be available. The technology poses no known risks to the patient, and therefore could be a safe alternative to current screening methods.