Novigenix SA, Epalinges, Switzerland.
Department of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
Clin Cancer Res. 2016 Sep 15;22(18):4604-11. doi: 10.1158/1078-0432.CCR-15-2057. Epub 2016 Apr 28.
A blood test for early detection of colorectal cancer is a valuable tool for testing asymptomatic individuals and reducing colorectal cancer-related mortality. The objective of this study was to develop and validate a novel blood test able to differentiate patients with colorectal cancer and adenomatous polyps (AP) from individuals with a negative colonoscopy.
A case-control, multicenter clinical study was designed to collect blood samples from patients referred for colonoscopy or surgery. Predictive algorithms were developed on 75 controls, 61 large AP (LAP) ≥1 cm, and 45 colorectal cancer cases and independently validated on 74 controls, 42 LAP, and 52 colorectal cancer cases (23 stages I-II) as well as on 245 cases including other colorectal findings and diseases other than colorectal cancer. The test is based on a 29-gene panel expressed in peripheral blood mononuclear cells alone or in combination with established plasma tumor markers.
The 29-gene algorithm detected colorectal cancer and LAP with a sensitivity of 79.5% and 55.4%, respectively, with 90.0% specificity. Combination with the protein tumor markers carcinoembryonic antigen (CEA) and CYFRA21-2 resulted in a specificity increase (92.2%) with a sensitivity for colorectal cancer and LAP detection of 78.1% and 52.3%, respectively.
We report the validation of a novel blood test, Colox®, for the detection of colorectal cancer and LAP based on a 29-gene panel and the CEA and CYFRA21-1 plasma biomarkers. The performance and convenience of this routine blood test provide physicians a useful tool to test average-risk individuals unwilling to undergo upfront colonoscopy. Clin Cancer Res; 22(18); 4604-11. ©2016 AACR.
用于早期检测结直肠癌的血液检测是一种用于检测无症状个体并降低结直肠癌相关死亡率的有价值的工具。本研究的目的是开发和验证一种新型血液检测方法，能够区分结直肠癌和腺瘤性息肉（AP）患者与阴性结肠镜检查个体。
设计了一项病例对照、多中心临床研究，以收集因结肠镜检查或手术而就诊的患者的血液样本。在 75 名对照、61 名 1cm 以上的大腺瘤（LAP）和 45 名结直肠癌病例中开发了预测算法，并在 74 名对照、42 名 LAP 和 52 名结直肠癌病例（23 期 I-II）以及 245 名病例中进行了独立验证，这些病例包括除结直肠癌以外的其他结直肠发现和疾病。该检测基于单独或与已建立的血浆肿瘤标志物联合表达在外周血单核细胞中的 29 个基因谱。
29 个基因算法检测结直肠癌和 LAP 的敏感性分别为 79.5%和 55.4%，特异性为 90.0%。与癌胚抗原（CEA）和 CYFRA21-2 等蛋白质肿瘤标志物联合使用，可提高特异性（92.2%），同时检测结直肠癌和 LAP 的敏感性分别为 78.1%和 52.3%。
我们报告了一种新型血液检测方法 Colox®的验证，该方法基于 29 个基因谱和 CEA 和 CYFRA21-1 血浆生物标志物用于检测结直肠癌和 LAP。这种常规血液检测的性能和便利性为医生提供了一种有用的工具，用于检测不愿意进行前期结肠镜检查的一般风险个体。临床癌症研究；22(18)；4604-11. ©2016 AACR。
