Screening for pancreatic cancer via nanocytology of duodenal cells

通过十二指肠细胞纳米细胞学筛查胰腺癌

• 批准号: 9048009
• 负责人: Lusik Surenovna Cherkezyan
• 金额: $ 22.5万
• 依托单位: NANOCYTOMICS, LLC
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-06-01 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9048009
• 关键词: Age; American; Anxiety; Architecture; Area; Benign; Biliary; Biophotonics; Brush Cell; Cancer Detection; Cancer Etiology; Cancer Patient; Cell Count; Cell Nucleus; Cells; Cessation of life; Chromatin; Clinical; Collection; Colon; Cystic Lesion; Cytoplasm; Data; Detection; Development; Diagnosis; Diagnostic; Diagnostic Neoplasm Staging; Disease; Duodenum; Endoscopes; Endoscopic Retrograde Cholangiopancreatography; Endoscopy; Epigenetic Process; Esophagogastroduodenoscopy; Esophagus; Excision; Family; Future; Genetic; Goals; Higher Order Chromatin Structure; Histologic; Islet Cell; Lead; Lesion; Licensing; Low Prevalence; Lung; Magnetic Resonance Imaging; Malignant Neoplasms; Malignant neoplasm of lung; Malignant neoplasm of pancreas; Measures; Methylation; MicroRNAs; Microscopy; Modality; Mucous Membrane; Multi-Institutional Clinical Trial; Neoplasm Metastasis; Nuclear; Obstruction; Operative Surgical Procedures; Pancreas; Pancreatitis; Patients; Phase; Population; Premalignant; Preparation; Probability; Procedures; Protocols documentation; ROC Curve; Recording of previous events; Refractive Indices; Risk; Risk Factors; Sampling; Screening for cancer; Screening procedure; Sedation procedure; Slide; Small Business Innovation Research Grant; Specimen; Staging; Staining method; Stains; Stratification; Techniques; Technology; Testing; United States; Unresectable; Variant; Vision; base; cancer risk; carcinogenesis; chronic pancreatitis; cohort; commercial application; cost; cytokine; diabetic; disorder control; high risk; nano; nanoscale; novel; outcome forecast; pancreatic juice; patient stratification; patient subsets; public health relevance; sample fixation; screening; specific biomarkers; statistics; tool; tumorigenic; upper GI series

 DESCRIPTION (provided by applicant): The goal of this SBIR project is to develop a minimally intrusive, highly-sensitive risk-stratification tool to determine the need for invasive pancreatic cancer (PC) screening. PC is the 4th leading cause of cancer deaths in the US. While early stage disease is generally curable, the vast majority of patients are diagnosed in advanced, unresectable stages due in large part to the lack of a suitable candidate screening technology. Unfortunately, all current screening modalities (ERCP or EUS) suffer from a very high false positive rate, high cost, invasiveness, and risk of serious complications. This underlines the urgent need for developing an effective test that targets PCat an early stage. The present project is based on a novel biophotonics technology that is exclusively licensed to NanoCytomics by Northwestern Univ., Partial Wave Spectroscopic (PWS) microscopy ('nanocytology'), that has been shown to sense and quantify nanoscale early-stage tumorigenic alterations within histologically normal- appearing cells. PWS uses the phenomenon of field carcinogenesis, the concept that the genetic/epigenetic alterations that lead to PC are also reflected in endoscopically normal periampullary duodenal mucosa either through shared risk factors or secreted factors (cytokines etc) from the pancreatic juice. Although the duodenal cells in PC patients appear endoscopically and microscopically normal, there are profound epigenetic alterations (e.g. methylation, microRNA etc.) whose nanoscale corollary (e.g., high-order chromatin) are detectable by partial PWS. The detection of nanoscale structural alterations of the fertile tumorigenic field may allow to risk-stratify patients with early-stage cancers or precancerous lesions located anywhere in duodenum. Thus, our preliminary data showed that the PWS-detectable nano-morphological alterations of periampullary duodenal cells are a highly sensitive and specific biomarker for PC. To perform the academic to commercial transition and establish duodenal nanocytology as a commercially-viable, minimally-intrusive, and highly-sensitive pre-screen for PC, several steps must be completed. In the present Phase I SBIR project, standard operating procedures (SOP) that are optimized for stability, reliability and diagnostic potential will be developed and validated. The future steps of this project will include refinement and optimization of the PWS markers in Phase II (thus enhancing its diagnostic power), followed by a multi-center clinical trial critical for the eventual regulatory approval. We envision that PWS analysis of cells brushed from the periampullary duodenal mucosa of high-risk patients (new onset diabetics, family history, chronic pancreatitis, etc.) as well as those undergoing EGD for other indications will serve as a gauge of risk/probability and can be used to risk stratify and hence tailor screening/surveillance decisions thus identifying the subset of patients who may benefit from further screening (such as a pancreatic CT/MRI or EUS/ERCP). In the long term, duodenal PWS can be combined with the existing upper GI screening by ultrathin EGD, thus allowing for a pan-upper GI cancer screening.

 描述（由申请人提供）：SBIR项目的目标是开发最小的侵入性，高度敏感的o确定对侵入性胰腺癌（PC）筛查的需求，而舞台疾病通常可以治愈，绝大多数患者被诊断出来。在缺乏合适的候选筛查技术的高级，不可或缺的阶段PCATS PCAT是基于西北大学的纳米细胞学，司法部的早期鼻鼻涕。 （细胞因子等）来自胰汁和显微镜，有深刻的表观遗传变化（例如甲基化，microRNA等），其纳米级推论（例如，高阶染色质）的nansoscale thection ial pws。现场可以允许具有早期癌症或癌前定位的to to to to to to to to to to to to to to to to Toe。为了开发和验证了未来的步骤这个项目将包括 II期的细化和优化（因此增强是诊断能力）E最终的规律性批准 设想对高危患者（新发作糖尿病）ONIC胰腺炎等细胞的PWS分析以及用于适应症的EGD的PWS分析，可以用作风险/概率的仪表，可以用作风险/概率。风险说明可能受益于Scree ning的患者的裁缝筛查/监视子集（例如，长期可以将Duodenal PW与现有的上GI筛选结合在一起EGD，因此可以进行泛upper gi癌筛查。