Department of Abdominal Medicine, Colorectal Cancer Clinical Research Center of Hubei Province, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430079, China.
Department of Blood Transfusion, Wuhan Hospital of Traditional Chinese and Western Medicine, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.
BMC Gastroenterol. 2022 Aug 13;22(1):384. doi: 10.1186/s12876-022-02470-z.
BACKGROUND: Stool DNA (sDNA) tests and fecal immunochemical test (FIT) are used for the detection of colorectal cancer (CRC). Here we performed a novel evaluation using sDNA and FIT to assess their performance in CRC screening and monitoring in Hubei, China. METHODS: Stool samples were collected from a high-risk population in Hubei, China (n = 359). sDNA tests and FIT were performed to test for KRAS mutations, NDRG4 and BMP3 methylation, and check hemoglobin levels. The methylation in BMP3 and NDRG4 genes was detected by TaqMan PCR method from human fecal samples. KRAS gene mutation in human fecal DNA was tested using TaqMan probe and amplification-refractory mutation system method. The colloid gold method was used for detection of hemoglobin in fecal samples. Finally, a novel evaluation by software was used to calculate the comprehensive value of the combined results for CRC detection and monitoring. RESULTS: The sensitivity and specificity of the novel evaluation for early CRC (stage I and II), advanced adenoma (AA), and non-colon cancer neoplasm (NA) detection were 95.45% and 81.6%, 29.63% and 75.9%, and 23.08% and 75.17%, respectively. The receiver operating characteristic (ROC) curves of the combined value for the above diseases were 0.945 ± 0.015, 0.543 ± 0.055, and 0.547 ± 0.038, respectively. The levels of the novel evaluation were not significantly associated with the pathology and stage (P > 0.05). In 20 out of 22 CRC patients, the novel evaluation of sDNA and FIT had decreased below threshold (< 165) at after surgery. DISCUSSION: The novel evaluation with sDNA test and FIT has increased sensitivity for screening of CRC and AA. The novel evaluation may have potential importance as an indicator of early CRC. Additionally, the dynamic changes of the comprehensive value after surgery were correlated with CRC treatment.
背景：粪便 DNA（sDNA）检测和粪便免疫化学检测（FIT）用于结直肠癌（CRC）的检测。在这里，我们使用 sDNA 和 FIT 进行了一项新的评估，以评估它们在中国湖北进行 CRC 筛查和监测的性能。
方法：从中国湖北高危人群中采集粪便样本（n=359）。进行 sDNA 检测和 FIT 以检测 KRAS 突变、NDRG4 和 BMP3 甲基化以及检查血红蛋白水平。采用 TaqMan PCR 法从人粪便样本中检测 BMP3 和 NDRG4 基因甲基化。采用 TaqMan 探针和扩增耐突变系统方法检测人粪便 DNA 中的 KRAS 基因突变。采用胶体金法检测粪便样本中的血红蛋白。最后，采用软件进行新的评估，计算联合结果对 CRC 检测和监测的综合价值。
结果：新型评估对早期 CRC（I 期和 II 期）、高级腺瘤（AA）和非结肠癌肿瘤（NA）的检测的敏感性和特异性分别为 95.45%和 81.6%、29.63%和 75.9%以及 23.08%和 75.17%。上述疾病联合值的受试者工作特征（ROC）曲线分别为 0.945±0.015、0.543±0.055 和 0.547±0.038。新型评估与病理和分期无显著相关性（P＞0.05）。在 22 例 CRC 患者中，有 20 例患者手术后 sDNA 和 FIT 的新型评估值均降至阈值以下（＜165）。
讨论：sDNA 检测和 FIT 的新型评估提高了 CRC 和 AA 的筛查敏感性。新型评估可能作为早期 CRC 的指标具有重要意义。此外，手术后综合值的动态变化与 CRC 治疗相关。
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