Development of a Blood Test for Colorectal Cancer based on Metabolomic Signature

结直肠癌（CRC）是西方世界癌症死亡的第二大原因。理想情况下，早期发现结直肠癌，因为在疾病晚期治疗变得越来越复杂，毒性和昂贵，并且在疾病早期生存率最高。这是筛选的基础。目前，筛查的金标准是结肠镜检查，这是一种侵入性的、昂贵的、难以在大量人群中进行的检查。一种策略是通过粪便测试（称为粪便免疫组化测试，FIT）来丰富需要结肠镜检查的亚群。问题是粪便测试的依从性低于40%，因为粪便测试是令人反感和不方便的。我们开发了一种基于血清化学成分的血液检测方法。这种测试非常敏感，已经在600多名患者身上进行了测试。在这个项目中，我们将与Med-LifeDiscoveries和Innovate Calgary以及一个多学科科学团队合作，进一步完善该测试，然后创建一种可用于典型临床实验室的诊断测试。将开发软件以增强分析测试结果的能力。最后，我们将对近3500名接受过结肠镜筛查的患者的血液样本进行新的诊断测试。最后，我们将有一个方便的，临床适用的测试，将在未来的更大的临床试验中进行测试，这将告知监管机构和临床医生这种新测试作为替代筛查工具的价值。

Colorectal cancer (CRC) is the second leading cause of cancer death in the western world.Ideally, CRC will be detected early because treatments become progressively morecomplicated, toxic and expensive in later disease stages, and the survival is best in earlystage of disease. That is the basis of screening. Currently, the gold standard screening test iscolonoscopy, which is invasive, expensive and difficult to perform on large populations. Onestrategy is to enrich the subgroup that requires a colonoscopy by doing a stool test (called afecal immunohistochemical test, FIT). The problem is that compliance for stool tests is lessthan 40% because testing stool is objectionable and inconvenient. We have developed ablood test based on the chemical composition of serum. This test is quite sensitive and it hasalready been tested on over 600 patients. In this project, in collaboration with Med-LifeDiscoveries and Innovate Calgary, as well as a multidisciplinary science team, we will furtherrefine the test, then create a diagnostic test that can be used in a typical clinical laboratory.Software will be developed to enhance the capability to analyze test results. Finally, we willtest the new diagnostic test on blood samples collected from close to 3500 individuals whohad screening colonoscopies. At the end, we will have a convenient, clinically applicable testthat will be tested in the future in a larger clinical trial that would inform regulatory agenciesand clinicians on the value of this new test as an alternative screening tool.