IGF::OT::IGF R&D- MEDICAL: BIOMEDICAL (BASIC RESEARCH)

IGF::OT::IGF R

• 批准号: 9152509
• 负责人: SUDHIR SINHA
• 金额: $ 30万
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-22 至 2016-06-21
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9152509
• 关键词: Basic Science; Biological Assay; Biological Markers; Blood; Cancer Detection; Colorectal Cancer; Complement; DNA purification; Diagnosis; Diagnostic; Diagnostic Neoplasm Staging; Diagnostic Procedure; Early Diagnosis; Elements; Genetic; Malignant Neoplasms; Medical; Methods; Monitor; Outcome; Pattern; Phase; Plasma; Postoperative Period; Procedures; Process; Publishing; Reaction; Sampling; Serum; Small Business Innovation Research Grant; Testing; Tumor stage; base; cancer type; cell free DNA; colon cancer patients; cost effective; improved; inhibitor/antagonist; minimally invasive; outcome forecast; prognostic; research and development

Effective cancer management depends on early diagnosis, accurate tumor staging, and consistent monitoring. However, many current diagnostic procedures are invasive, expensive and unpleasant. In multiple recent published studies, circulating cell-free DNA (cfDNA) concentration and integrity (fragmentation pattern) has shown promise as a highly sensitive and specific, minimally invasive blood biomarker for multiple cancer types. InnoGenomics has a proprietary process enabling the most commonly employed genetic targets for this application, high copy number retrotransposable elements of varying sizes, to be simultaneously assayed in a highly sensitive multiplex qPCR reaction, with the inclusion of an internal positive control to monitor the presence of PCR inhibitors potentially present in blood serum or plasma. This SBIR Phase I project will focus on developing and evaluating the feasibility of a retrotransposable element based multiplexed qPCR assay to robustly quantitate and distinguish cfDNA integrity and concentration in blood plasma and serum from colorectal cancer (CRC) patients and control subjects. Such an assay will provide an accurate, minimally-invasive, rapid, high-throughput, and cost-effective method with the potential to complement or replace existing procedures for CRC detection, diagnosis, prognosis, treatment monitoring and/or surveillance, thereby improving CRC patient outcomes.

有效的癌症管理取决于早期诊断，准确的肿瘤分期和一致的监测。然而，许多当前的诊断程序是侵入性的，昂贵的和不愉快的。在最近发表的多项研究中，循环无细胞DNA（cfDNA）浓度和完整性（片段化模式）已显示出作为多种癌症类型的高度敏感和特异性，微创血液生物标志物的前景。InnoGenomics拥有一种专有工艺，能够在高度灵敏的多重qPCR反应中同时测定本申请中最常用的遗传靶标（不同大小的高拷贝数逆转录转座因子），并包含内部阳性对照，以监测血清或血浆中可能存在的PCR抑制剂的存在。该SBIR I期项目将专注于开发和评估基于逆转录转座因子的多重qPCR测定的可行性，以稳健地定量和区分来自结直肠癌（CRC）患者和对照受试者的血浆和血清中的cfDNA完整性和浓度。这样的测定将提供准确、微创、快速、高通量和成本有效的方法，具有补充或替代现有的CRC检测、诊断、预后、治疗监测和/或监视程序的潜力，从而改善CRC患者的结果。