Diagnosis of Cervical Precancers Using Raman Spectroscopy

描述(申请人提供)：宫颈癌是全世界女性中第二常见的恶性肿瘤。据估计，2007年，仅在美国就有3670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50年中，早期发现宫颈癌前病变在降低与该疾病相关的死亡率方面发挥了重要作用，但宫颈浸润性前鳞癌的发病率仍较低。当宫颈癌被及早发现时，它们是高度可治愈的。现有的筛查和检测技术，如巴氏涂片和阴道镜，有几个缺陷，阻碍了对原本可控的疾病的有效管理。一种具有更高的灵敏度和特异度的自动化诊断方法将显著改善对疾病的管理，这种方法可以允许“查看并治疗”方案。这项建议旨在证明这样一个假设，即拉曼光谱可以为宫颈癌前病变提供鉴别诊断，包括与炎症、鳞状化生和正常宫颈区域的高级别和低级别的鉴别诊断。这项建议的主要目的是确定和验证低级别病变可以与高级别病变以及正常宫颈区分开来，并且无论患者的绝经状态如何，这种诊断都可以进行。这将通过进行大规模的临床调查来实现，收集正常和疾病宫颈的拉曼光谱，按组织类别分离它们，并通过多类判别算法对它们进行分类。此外，随着组织光谱特征的独特模型的发展，我们试图使用该模型来理解疾病过程，因为它应用于光学光谱学。最后，该系统将被更新为尽可能紧凑，开发的软件将为临床使用而“容易”(一键收集和分类一种光谱)。拟议工作的结果将对卫生保健产生重大影响，因为它提供了利用单一检测工具进行全面疾病管理的可能性。这将带来更好的病人护理和成本效益。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，从而影响到更广泛的医学领域。与公共卫生相关：宫颈癌是全世界女性中第二常见的癌症类型。早期发现宫颈癌前病变是在该疾病转化为癌症之前对其进行适当治疗的关键。今天使用的检测宫颈癌前病变的方法在识别低级别和高级别疾病与其他非正常情况下的能力方面是有限的。这项建议提出了一种实时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、更便宜的筛查和诊断宫颈异型增生的方法。拉曼光谱技术能够实现“先看后治疗”方案，这将减少返回诊所的次数和患者的焦虑，因为等待组织病理学诊断的漫长等待将被消除。因此，这项技术有可能增加对那些可能无法获得筛查后续行动的服务不足人群的接触。这项技术对患者没有已知的风险，因此可能是目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.