Novel Biophotonics Methodology for Colon Cancer Screening

描述(由申请人提供)：这是一项建立生物工程研究伙伴关系(BRP)的建议，以开发一种新的用于全人群结直肠癌(CRC)筛查的生物光子学方法。虽然结肠镜检查在诊断和预防恶性肿瘤方面都有显著的效果，但结直肠癌仍然是癌症死亡的第二大原因，这主要是因为绝大多数美国人(80%)没有接受结肠镜检查。不幸的是，由于成本、患者不依从性、并发症和缺乏足够的内窥镜检查能力，通过结肠镜检查整个符合条件的人群(&gt；8700万50岁以上的美国人)实际上是不可能的。不是对整个人群进行结肠镜检查，而是针对患肿瘤的高危人群，可以将有限的内窥镜资源集中在实际上将从这项测试中受益的受试者身上。然而，现有的结肠镜前筛查试验都没有足够的灵敏度和预测价值。拟议的计划基于两种新的互补生物光子学技术，弹性光散射指纹(ELF)和低相干增强后向散射(LEBS)光谱，由我们的多学科团队开发，成员包括生物医学和电气工程师、物理学家、胃肠病学家、癌症生物学家和生物统计学家。ELF和LEBS的一个关键功能是，它们能在远离癌前病变的地方感知组织学上正常组织的变化。这些光谱标记物是目前已知的、高度准确和实用的检测结肠癌“场效应”的唯一手段。这为仅通过评估组织学和结肠镜下正常的直肠黏膜来识别可能存在肿瘤的患者打开了可能性。根据我们的初步数据，我们假设ELF/LEBS将能够根据直肠黏膜的光学变化来识别在结肠的任何地方有和没有肿瘤的受试者，这将在不需要结肠镜和肠道准备的情况下进行评估。缺乏肠道准备和前所未有的敏感性可能使拟议的技术成为结肠镜检查前CRC筛查的理想工具。我们建议开发临床医生认为用户友好的仪器，并使用4000名患者进行明确的多中心验证研究。一旦完成，这种方法将为第一次全人群范围的结直肠癌筛查提供一个巨大的飞跃。 公共卫生相关性：虽然结肠镜检查在预防结肠癌方面是有效的，但使用结肠镜检查进行人群筛查实际上是不可能的，迫切需要开发一种初步的结肠镜检查前筛查测试。我们建议开发一种基于新的生物光子学技术的非侵入性检测方法，用于人群结肠癌筛查。这项测试将要求在没有结肠镜检查和肠道准备的情况下对直肠组织进行光学检查，并将确定整个结肠是否存在癌前病变。将来，这项测试可以在初级保健医生进行年度检查时实施，以确定是否需要结肠镜检查。

DESCRIPTION (provided by applicant): This is a proposal to establish a Bioengineering Research Partnership (BRP) to develop a novel biophotonics methodology for population-wide colorectal cancer (CRC) screening. While colonoscopy has remarkable efficacy at both diagnosis and malignancy prevention, CRC remains the second leading cause of cancer deaths largely because the vast majority (>80%) of Americans do not undergo colonoscopy. Unfortunately, screening the entire eligible population (>87 million Americans over age 50) through colonoscopy is practically impossible because of cost, patient non-compliance, complications and lack of sufficient endoscopic capacity. Instead of performing colonoscopy on the entire population, targeting the group at risk for developing neoplasia would allow focusing of this finite endoscopic resource on subjects who will actually benefit from this test. However, no existing pre-colonoscopic screening test has adequate sensitivity and predictive value. The proposed program is based on two novel, complementary biophotonics techniques, elastic light scattering fingerprinting (ELF) and low-coherence enhanced backscattering (LEBS) spectroscopy developed by our multidisciplinary team comprised of biomedical and electrical engineers, physicists, gastroenterologists, cancer biologists, and biostatisticians. A key capability of ELF and LEBS is that they sense changes in histologically normal tissue at a distance from a precancerous lesion. These spectral markers represent the only currently known, highly accurate and practical means of detecting the "field effect" of colon cancer. This opens a possibility to identifying patients who may harbor neoplasia by assessment of histologically and colonoscopically normal-appearing rectal mucosa only. Based on our preliminary data, we hypothesize that ELF/LEBS will be able to identify subjects who do and do not harbor neoplasia anywhere in the colon based on the optical alterations in the rectal mucosa that will be assessed without the need for colonoscopy and bowel preparation. The lack of bowel preparation and the unprecedented sensitivity may make the proposed technique an ideal tool for pre-colonoscopy CRC screening. We propose to develop instrumentations that clinicians will find user friendly and perform a definitive multicenter validation study using 4000 patients. Once completed, this approach will provide a quantum leap towards the first population-wide CRC screening. PUBLIC HEALTH RELEVANCE: Although colonoscopy is efficient at colon cancer prevention, it is practically impossible to use colonoscopy for population screening and the development of an initial, pre-colonoscopy screening test is urgently needed. We propose to develop a non-invasive test for population colon cancer screening that is based on a new biophotonics technology. The test will require the optical examination of rectal tissue without colonoscopy and bowel preparation and will identify the presence of precancerous lesions throughout the entire colon. In the future, this test can be implemented during an annual exam by a primary care physician to determine the need for colonoscopy.