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Colon cancer risk-stratification via optical analysis of rectal ultrastructure

通过直肠超微结构的光学分析进行结肠癌风险分层

基本信息

批准号：
9337414
负责人：
Eric Daniel Benson
金额：
$ 83.57万
依托单位：
AMERICAN BIOOPTICS, LLC
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-09-01 至 2021-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9337414
关键词：
Adenomatous Polyps Age Age-Years Algorithmic Software Algorithms American Animals Area Biophotonics Cancer Etiology Cancerous Cessation of life Clinical Colon Colon Carcinoma Colonic Adenoma Colonoscopy Colorectal Cancer Data Detection Development Diagnostic Diet Diffuse Disinfection Dysplasia Eligibility Determination Engineering Ensure Epigenetic Process Event Excision Exhibits FDA approved Fiber Optics Future General Population Generations Genetic Goals Gold Grant Guidelines Health system Higher Order Chromatin Structure Histologic Hospitals Human Individual Injury Intestines Lead Length Lesion Life Methodology Microscopy Molecular Morphology Mucous Membrane Multi-Institutional Clinical Trial Mutation Neoplasms Optics Organ Pathway interactions Patient Schedules Patients Pilot Projects Population Populations at Risk Premalignant Preparation Primary Care Physician Primary Health Care Procedures Protocols documentation Provider Publishing Reading Rectal Cancer Rectum Research Resolution Risk Risk Factors Risk stratification Safety Savings Science Small Business Innovation Research Grant Smoking Specificity Standardization System Techniques Technology Testing Time Tissues Touch sensation Universities Update Validation Villous adenoma base blind carcinogenesis clinical application clinically relevant cohort colorectal cancer screening commercialization cost cost effective design extracellular in vivo instrumentation minimal risk minimally invasive nanoscale neoplastic novel patient subsets primary care setting prospective public health relevance rectal screening sensor success

项目摘要

DESCRIPTION (provided by applicant): The goal of this small business innovation research grant is to develop and commercialize a highly accurate, minimally invasive risk stratification technique for colorectal cancer (CRC) that is simple enough to be performed by the primary care provider during an annual physical exam. Although existing guidelines recommend CRC screening for all patients over age 50 (>100 million Americans), CRC remains the second leading cause of cancer death. This is in part due to the limitations in the existing CRC screening techniques including colonoscopy which is considered a `gold standard' for CRC screening. This is because only a small fraction of eligible population undergoes colonoscopy due to variety of reasons including expense, patient reluctance, complications, and insufficient number of endoscopists. Furthermore, the current practice of colonoscopy on the "average risk" population is remarkably inefficient as only ~6% of the screening population have significant neoplasia (advanced adenomas). Hence developing a minimally invasive test to identify patients who do and do not harbor colonic adenomas is of crucial importance to better target patients for colonoscopy. This would enable, for the first time, a population wide screening for CRC. An interdisciplinary team of engineers, biologists and clinicians at Northwestern University and Northshore University Health System has developed Low-Coherence Enhanced Backscattering (LEBS), a novel biophotonic technique that enables sensing the nanoscale tissue morphological correlates of the genetic/epigenetic changes in otherwise histopathologically normal mucosa. Preliminary animal and human studies demonstrated the potential of LEBS to detect subtle alterations in histologically normal- appearing tissue that is due to the presence of cancerous/precancerous lesions present in a different part of an organ, a consequence of the well-established concept of field carcinogenesis. This opens a possibility to detect the presence of colonic neoplasia by means of real-time LEBS analysis of rectal tissue mucosa, which is readily available upon blind insertion of the minimally invasive LEBS probe in PC or OBGYN setting. Indeed, in pilot studies on ~500 patients (with bowel preparation for colonoscopy), it was noted that the LEBS marker from endoscopically-normal rectal mucosal readings mirrored the significance of neoplastic lesions elsewhere in the colon (advanced adenomas > adenomas > no neoplasia). There are several steps that are required prior to the future definitive clinical validation of rectal LEBS analysis. In In year 1 of the grant period, instrumentation will be developed necessary to transition the LEBS technology from its initial product configuration intended for use in GI hospital-based setting, to a configuration allowing for use in PC and OBGYN settings, and a rectal LEBS trial will be conducted of 250 patients who will later undergo colonoscopy, and a LEBS prediction rule will be subsequently formulated. In year 2 of the grant period, the prediction rule will be verified via an independent cohort of 250 unprepped patients scheduled for colonoscopy, where the previously developed rectal LEBS prediction rule will be prospectively applied for both advanced adenomas and any adenomas. The successful SBIR research would enable American BioOptics to create a commercially viable diagnostic system that would be critical for future multi-center clinical trials and FDA approval.