Nanocytological Fecal Assessment to Personalize Colonoscopic Surveillance

纳米细胞粪便评估以个性化结肠镜监测

• 批准号: 8727274
• 负责人: Hemant K. Roy
• 金额: $ 76.93万
• 依托单位: NANOCYTOMICS, LLC
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8727274
• 关键词: American; Area; Biomedical Engineering; Biophotonics; Businesses; Cancer Etiology; Cells; Cessation of life; Clinical; Clinical Trials; Collection; Colon; Colonoscopy; Colorectal; Colorectal Cancer; DNA; DNA Methylation; Data; Detection; Development; Epithelial; Feces; Future; Gastroenterologist; Genetic; Goals; Grant; Healthcare; Hemoglobin; Individual; Internal Medicine; Lead; Legal; Lesion; Maintenance; Malignant Neoplasms; Malignant neoplasm of lung; Marketing; Microsatellite Repeats; Microscopy; Modality; Modeling; Molecular; Mucous Membrane; Mucous body substance; Natural History; Neoplasms; Occult blood screen; Optics; Ovarian; Patient Schedules; Patients; Phase; Physicians; Polypectomy; Procedures; Recording of previous events; Recruitment Activity; Recurrence; Resources; Right colon; Risk; Schedule; Small Business Technology Transfer Research; Source; Speed; Surgeon; Techniques; Technology; Technology Transfer; Testing; Time; Training; Translating; Universities; Validation; adenoma; base; cancer diagnosis; carcinogenesis; clinical application; clinical practice; colorectal cancer prevention; colorectal cancer screening; commercialization; cost; follow-up; high risk; improved; instrument; instrumentation; interest; light scattering; multidisciplinary; nanoscale; neoplastic; neoplastic cell; new technology; novel; prevent; product development; rectal; screening; tumor

DESCRIPTION (provided by applicant): The clinical impact of the 5 million annual surveillance colonoscopies (follow up of previous neoplasia) is remarkably low (>90% without significant neoplasia). Juxtaposed with this is the alarmingly frequent occurrence of colorectal cancers (CRCs) in between colonoscopies (interval cancers), especially in the proximal colon. The medico-legal and clinical consequences of interval CRCs lead to vast overuse of surveillance colonoscopy engendering unnecessary cost, complications etc. Fecal tests represent an attractive potential adjunct although the typical tests (occult blood, DNA, methylation) have a poor (~10-40%) sensitivity for advanced adenomas, the target of CRC prevention efforts. Our multidisciplinary CRC prevention group has developed a mucus layer fecal colonocyte biophotonics test that allows detection of both field carcinogenesis along with the less abundant tumor products. We have employed our ultrasensitive novel technology, partial wave spectroscopic microscopy (PWS). PWS allows, for the first time, a practical modality to quantify nanoscale architectural colonic epithelial alterations in preclinica models (PNAS, 2008). We have demonstrated that colonocyte PWS analysis has a ~90% accuracy of identifying individuals for colonic advanced adenomas throughout the colon (n=141) (Gastro, 2011). In order for Nanocytomics to commercialize fecal PWS for tailoring colonoscopic screening intervals, we propose to develop a high throughput instrument (phase 1) with milestones of accuracy and speed (<10 minutes per patient). Phase 2 will involve clinical trials in two common scenarios: 1. Determine whether a patient scheduled for colonoscopy can be safely postponed (n=200 training and 200 testing set) 2. Investigate whether a patient needs to have an expedited colonoscopy (n=250). These will be compared to conventional fecal tests (immunohistochemical and DNA). These studies will be instrumental to bridge the power of PWS to the clinical application off colonoscopic screening interval personalization thus representing a large and well defined commercial opportunity. Furthermore, identification of field carcinogenesis with PWS is a platform with clear applications for average risk CRC screening along with other cancers (lung, ovarian etc).

描述（由申请人提供）： 每年500万次监测结肠镜检查（以前的肿瘤的随访）的临床影响非常低（> 90％，没有明显的肿瘤）。与此并置的是结肠镜（间隔癌）之间的结直肠癌（CRC）的频繁出现，尤其是在近端结肠中。间隔CRC的医疗法律和临床后果导致大量过度使用监视结肠镜检查，使不必要的成本，并发症等。粪便测试代表了有吸引力的潜在辅助功能 （神秘的血液，DNA，甲基化）对晚期腺瘤的敏感性较差（约10-40％），这是CRC预防工作的靶标。我们的多学科CRC预防组已开发出粘液层粪便结肠生物素化学测试，该测试允许检测两种野外致癌作用以及较少的肿瘤产物。我们采用了超灵敏的新技术，部分波光谱显微镜（PWS）。 PWS首次允许使用一种实用的方式来量化珠珠肽模型中的纳米级结构结肠上皮变化（PNAS，2008年）。我们已经证明，结肠细胞PWS分析的精度约为90％，可以在整个结肠中识别菌落晚期腺瘤的个体（n = 141）（astroto，2011）。为了使纳米细胞学学以量身定制结肠镜检查间隔，使粪便PW商业化，我们建议开发具有准确性和速度里程碑的高吞吐量仪器（阶段1）（每位患者<10分钟）。第2阶段将在两个常见情况下进行临床试验：1。确定计划进行结肠镜检查的患者是否可以安全推迟（n = 200训练和200个测试集）2。研究患者是否需要加快结肠镜检查（n = 250）。这些将与常规的粪便测试（免疫组织化学和DNA）进行比较。这些研究将有助于桥接PW的力量，以在结肠镜检查间隔内实现临床应用，从而代表了一个较大且定义明确的商业机会。此外，用PWS鉴定现场致癌作用是一个平台，并与其他癌症（肺，卵巢等）一起进行了平均风险CRC筛查的清晰应用。