Li Y L, Guan X, Dou L Z, Liu Y, Huang H Y, Huang S K, Yang Z X, Wei B J, Wu Y, Chen Z H, Wang G Q, Wang Xishan, Cui Wei
Department of Medical Laboratory, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
Department of Colorectal Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
Zhonghua Yi Xue Za Zhi. 2022 Sep 6;102(33):2607-2613. doi: 10.3760/cma.j.cn112137-20220430-00974.
To investigate the clinical diagnostic value of multi-target stool fecal immunochemical test-DNA (FIT-DNA) test in colorectal cancer (CRC) and advanced adenoma (AA). A total of 235 patients who were undergoing colonoscopy or colorectal cancer surgery in the Cancer Hospital, Chinese Academy of Medical Sciences from April 2021 to January 2022 were prospectively enrolled. There were 141 males and 94 females, with an average age of (55±13) years (22-86). The patients were divided into two groups, including 215 patients who were first diagnosed but not treated (86 cases of CRC, 12 cases of AA, 25 cases of non-advanced adenoma, 8 cases of hyperplastic or other polyps and 84 apparently healthy cases) and 20 patients in the intervention group (2 cases with a history of CRC surgery, 6 cases with a history of endoscopic surgery, 4 non-CRC patients with special diseases and 8 cases with a history of neoadjuvant chemoradiotherapy). Fresh stool samples were collected before intestinal preparation or surgery for FIT-DNA test using the matching kit for sample processing and nucleic acid purification. KRAS mutation and methylation of BMP3 and NDRG4 genes were detected by fluorescence probe method, and FIT method was employed to detect fecal occult blood. Colonoscopy or pathological biopsy results were used as the gold standard. And the screening and diagnostic efficacy of FIT-DNA test for colorectal cancer and advanced adenoma were evaluated by receiver operating curve (ROC). The sensitivity of FIT-DNA test for early colorectal cancer and advanced adenoma was 7/7 and 8/12, respectively. And the negative predictive value was 98.1% (104/106) and 93.7% (104/111), respectively. The overall screening sensitivity for both early colorectal cancer and advanced adenoma was 15/19, and the negative predictive value was 96.3% (104/108). Besides, the area under the curves (AUCs) were 0.982 (95%: 0.960-1.000, <0.05), 0.758 (95%: 0.592-0.924, <0.05) and 0.841 (95%: 0.724-0.957, <0.05), respectively. Moreover, the diagnostic sensitivity of FIT-DNA test was 98.8% (85/86) for colorectal cancer, 8/12 for advanced adenoma, and 94.9% (93/98) for both colorectal cancer and advanced adenoma, with a specificity of 88.9% (104/117). The AUCs were 0.968 (95%: 0.937-0.997, <0.05), 0.758 (95%: 0.592-0.924, <0.05) and 0.942 (95%: 0.905-0.979, <0.05), respectively. After the inclusion of intervention group, the overall diagnostic sensitivity and specificity of FIT-DNA test was 91.6% (98/107) and 89.1% (114/128), respectively. FIT-DNA test has a high early screening and diagnostic efficacy for colorectal cancer.
探讨多靶点粪便免疫化学检测-脱氧核糖核酸（FIT-DNA）检测在结直肠癌（CRC）和高级别腺瘤（AA）中的临床诊断价值。前瞻性纳入2021年4月至2022年1月在中国医学科学院肿瘤医院接受结肠镜检查或结直肠癌手术的235例患者。其中男性141例，女性94例，平均年龄（55±13）岁（22-86岁）。患者分为两组，包括215例初诊未治疗患者（86例CRC、12例AA、25例非高级别腺瘤、8例增生性或其他息肉以及84例明显健康者）和20例干预组患者（2例有CRC手术史、6例有内镜手术史、4例非CRC特殊疾病患者以及8例有新辅助放化疗史）。在肠道准备或手术前采集新鲜粪便样本，使用配套试剂盒进行样本处理和核酸纯化，以进行FIT-DNA检测。采用荧光探针法检测KRAS突变以及BMP3和NDRG4基因的甲基化，采用FIT法检测粪便潜血。以结肠镜检查或病理活检结果作为金标准。通过受试者操作特征曲线（ROC）评估FIT-DNA检测对结直肠癌和高级别腺瘤的筛查及诊断效能。FIT-DNA检测对早期结直肠癌和高级别腺瘤的敏感性分别为7/7和8/12。阴性预测值分别为98.1%（104/106）和93.7%（104/111）。对早期结直肠癌和高级别腺瘤的总体筛查敏感性为15/19，阴性预测值为96.3%（104/108）。此外，曲线下面积（AUC）分别为0.982（95%：0.960-1.000，P<0.05）、0.758（95%：0.592-0.924，P<0.05）和0.841（95%：0.724-0.957，P<0.05）。此外，FIT-DNA检测对结直肠癌的诊断敏感性为98.8%（85/86），对高级别腺瘤为8/12，对结直肠癌和高级别腺瘤两者为94.9%（93/98），特异性为88.9%（104/117）。AUC分别为0.968（95%：0.
