Biophotonics Noninvasive Detection of Ovarian Cancer

描述（由申请人提供）：卵巢癌是所有主要癌症中最致命的一种。虽然早期疾病通常可以通过手术治愈，但大多数妇女被诊断出的症状是晚期疾病的先兆。这突出了筛查无症状妇女的紧迫性。然而，目前的技术都没有临床推荐，因为无法准确识别高危女性。因此，必须开发一种高度准确、侵入性最小、廉价的检测方法，在早期阶段针对临床重要（侵袭性）疾病。理想情况下，这可以与巴氏涂片程序相结合。我们提出了一种新的卵巢癌筛查策略，其基础是通过我们的新型生物光子学方法在临床实用部位（子宫内膜或子宫颈）识别卵巢区域癌变，该方法类似于我们在结肠、肺和胰腺中的成功方案。该方法的可行性是由以下事实强调的：卵巢癌的最具侵袭性的浆液性亚型（迄今为止卵巢癌死亡率的主要原因）最初在卵巢外，在输卵管伞部中发展。因此，与输卵管相邻的妇科道的其他区域（例如子宫内膜和子宫颈内膜）已显示出致癌作用改变。虽然显微镜下正常，但该领域的细胞获得了许多改变，包括遗传，表观遗传和纳米结构。这提供了一个机会，通过检测场效应在一个容易接近的网站，如子宫内膜或子宫颈卵巢癌的风险分层。因此，需要对这些患者进行更严格和更积极的评估。这些纳米结构的变化可以通过一种新的生物光子学技术，部分波光谱（PWS）显微镜以实用和高度准确的方式检测。我们的试验数据表明，子宫内膜和宫颈细胞的纳米结构的改变是非常敏感的领域致癌，因此，可以作为一个强大的生物标志物卵巢癌。在这项研究中，我们将探索使用PWS检测这些纳米级改变的可行性，重点是早期，可治愈的卵巢癌。我们将验证人口统计学、风险因素和非卵巢恶性肿瘤和非肿瘤性病变方面没有混杂因素。该项目将为未来更大规模的临床验证提供必要的数据。这种新的模式可以改变卵巢癌筛查的临床实践。我们设想这种测试可以由妇科医生在年度检查中进行，类似于宫颈癌的宫颈涂片。 卵巢癌是所有主要癌症中最致命的一种，目前没有有效的筛查。我们提出了一种新的微创卵巢癌筛查策略，该策略将由妇科医生在年度检查中进行，类似于宫颈癌的宫颈涂片。

DESCRIPTION (provided by applicant): Ovarian cancer is one of the deadliest of all major cancers. While early stage disease is generally curable with surgery, most women are diagnosed because of symptoms which are a harbinger of advanced disease. This underscores the urgency for screening asymptomatic women. However, none of the current techniques are clinically recommended because of the inability to accurately identify at-risk women. Therefore, it is mandatory to develop a highly accurate, minimally intrusive, inexpensive test that targets clinically important (aggressive) disease at an early stage. Ideally this could be coupled with the Pap smear program. We propose a new ovarian cancer screening strategy based on identifying ovarian field cancerization at a clinically practical site (endometrium or cervix) through our novel biophotonics approach analogous with our successful programs in the colon, lung and pancreas. The feasibility of the approach is underscored by the fact that the most aggressive serous subtype of ovarian cancer (by far the leading cause of ovarian cancer mortality) initially develops outside of the ovary, in the fimbrae of the fallopian tubes. Accordingly, other areas of the gynecological tract that are contiguous with the fallopian tubes (e.g. endometrium and endocervix) have been shown to exhibit field carcinogenesis alterations. Although microscopically normal, cells in this field acquire a number of alterations including genetic, epigenetic and nanoarchitectural. This presents an opportunity to risk- stratify for ovarian cancer through detection of the field effect in a readily accessible site such as endometrium or cervix. More rigorous and aggressive evaluation of these patients would then be warranted. These nanoarchitectural changes can be detected in a practical and highly accurate fashion via a novel biophotonics technology, partial wave spectroscopic (PWS) microscopy. Our pilot data show that the alteration of nanoscale architecture in endometrial and cervical cells is exquisitely sensitive to field carcinogenesis and, hence, may serve as a robust biomarker for ovarian cancer. In this study, we will explore the feasibility of using PWS to detect these nanoscale alterations focusing on early stage, curable ovarian cancers. We will validate that there is no confounding with regards to demographics, risk factors and non-ovarian malignancies and non-neoplastic lesions. This project will provide the requisite data for future larger scale clinical validation. This novel paradigm could transform the clinical practice of ovarian cancer screening. We envision that this test can be performed by a gynecologist during an annual exam, similar to the pap-smear for cervical neoplasia. PUBLIC HEALTH RELEVANCE: Ovarian cancer is one of the deadliest of all major cancers with no effective screening currently available. We propose a new, minimally invasive ovarian cancer screening strategy that would be performed by a gynecologist during an annual exam, similar to the pap-smear for cervical neoplasia.