A Novel Technology for Capturing Fecal HUMAN DNA

描述（由申请人提供）：本项目致力于开发一种强大而有效的方法，从粪便中分离人类DNA，用于结肠直肠癌（CRC）的粪便DNA筛查。结直肠癌是美国第二致命的癌症，早期发现是根除这种疾病的关键。现有的方法既不敏感又无创，导致患者依从率低。非敏感性或侵袭性结直肠癌导致的不必要死亡，导致患者依从率低。由于筛查率低，CRC造成不必要的死亡，这使得纠正这一问题成为一个紧迫的社会优先事项。粪便DNA检测是CRC筛查中最有前途的方法之一。然而，粪便DNA检测的一个主要技术障碍是分离出的肿瘤来源DNA的数量可能很低，这使得筛查既不可靠又不敏感。我们最近发现了一种新的方法，这种方法可以很容易地将粪便DNA捕获提高4-32倍，并且可以稳定地恢复50%以上的人类DNA。第一阶段的目标是进一步发展这种新方法。具体的里程碑是证明它可以使从粪便中提取的人类DNA数量平均增加6倍。本研究由两部分组成。首先是开发从粪便中捕获人类DNA的优化程序。还将采取措施稳定粪便DNA，防止其降解。阶段1的第二部分是证明使用这种新方法可以实现所述的里程碑。将新方法与现有方法进行比较，对里程碑进行定量研究。将通过从患者的粪便样本中提取人类DNA来进行头对头比较。值得注意的是，虽然这种新方法是为粪便DNA检测而开发的，但它可以作为从任何临床标本中捕获人类DNA的通用方法。

DESCRIPTION (provided by applicant): This project focuses on the development of a robust and efficient method to isolate human DNA from stool for fecal DNA screening of colorectal cancer (CRC). CRC is the second deadliest cancer in the USA and early detection is the key to eradication of this disease. Existing methods are neither sensitive nor noninvasive, leading to a low patient compliance rate. The needless death from CRC that occurs as either not sensitive or invasive, leading to a low patient compliance rate. The needless death from CRC that occurs as a consequence of this low rate of screening makes correction of the problem an urgent social priority. Fecal DNA testing is emerging as 1 of the most promising methods for CRC screening. However, a major technical barrier to fecal DNA testing has been that the quantity of the tumor-derived DNA isolated can be low, making screening both less robust and less sensitive. We recently discovered a new method, with which the stool DNA capturing was readily improved by 4-32 fold and over 50% of human DNA were robustly recovered. The aim of Phase I is to further develop this new method. The specific milestone is to demonstrate that it can give an average 6-fold increase in the quantity of human DNA that can be retrieved from stool. This study consists of 2 parts. The first is to develop the optimized procedure for capturing human DNA from stool. Care will also be taken to stabilize the stool DNA from degradation. The second part of Phase I is to demonstrate that the stated milestone can be achieved using this new method. The milestone will be quantitatively studied by comparing this new method with the existing method. The head-to-head comparison will be made by extracting human DNA from the stool samples of patients. It is noted that although this new method is developed for fecal DNA testing, it can serve as a universal method for capturing human DNA from any clinic specimens.