Li Cong, Zhang Weili, Chen Qichen, Xiao Fei, Yang Xia, Xiao Binyi, Cheng Yanshuang, Qin Jiayi, Li Xueying, Wan Desen, Pan Zhizhong, Peng Jianhong, Wu Xiaojun
Department of Colorectal Surgery, Sun Yat-Sen University Cancer Center, 651 East Dongfeng Road, Yuexiu District, Guangzhou, 510060, China.
Department of Clinical Laboratory, People's Hospital of Maoming, Maoming, China.
Sci Rep. 2025 Apr 28;15(1):14759. doi: 10.1038/s41598-025-98968-z.
Colorectal cancer (CRC) diagnosis is challenging due to generalized symptoms. Various biomarker models exist, but their clinical application is limited by low sensitivity and heterogeneous cutoff values. This study aimed to develop and validate a diagnostic model for CRC. Data from 489 patients-337 with CRC and 152 with benign disease-were included. Patients were randomly assigned to training (n = 342) and validation (n = 147) cohorts. Logistic regression identified age (OR 1.06), CA153 (OR 0.26), CEA (OR 4.49), CYFRA 21-1 (OR 5.88), ferritin (OR 0.15), and hs-CRP (OR 0.05) as independent risk factors. Sensitivity and specificity were 88.61% and 82.86% in the training cohort and 90.00% and 76.60% in the validation cohort. Cutoff values for the biomarkers were: CA199, 9.809 U/mL; CA125, 7.743 U/mL; CA153, 6.295 U/mL; CEA, 3.982 ng/mL; CYFRA 21-1, 1.769 ng/mL; ferritin, 163.361 mg/L; hs-CRP, 0.196 mg/L; and serum albumin, 55.966 g/L. The model showed higher sensitivity for early-stage CRC (95.45%, 95% CI 87.2-98.6%) than late-stage CRC (87.27%, 95% CI 76.4-93.5%; P = 0.08). AUCs were 0.907 (training) and 0.872 (validation). The model demonstrated higher sensitivity for early-stage CRC (95.45%) than late-stage CRC (87.27%), underscoring its utility in early detection.
由于症状不具特异性，结直肠癌（CRC）的诊断颇具挑战性。现有多种生物标志物模型，但其临床应用因敏感性低和临界值异质性而受限。本研究旨在开发并验证一种CRC诊断模型。纳入了489例患者的数据，其中337例为CRC患者，152例为良性疾病患者。患者被随机分配至训练队列（n = 342）和验证队列（n = 147）。逻辑回归确定年龄（OR 1.06）、CA153（OR 0.26）、癌胚抗原（CEA）（OR 4.49）、细胞角蛋白19片段（CYFRA 21-1）（OR 5.88）、铁蛋白（OR 0.15）和超敏C反应蛋白（hs-CRP）（OR 0.05）为独立危险因素。训练队列中的敏感性和特异性分别为88.61%和82.86%，验证队列中的敏感性和特异性分别为90.00%和76.60%。生物标志物的临界值为：CA199，9.809 U/mL；CA125，7.743 U/mL；CA153，6.295 U/mL；CEA，3.982 ng/mL；CYFRA 21-1，1.769 ng/mL；铁蛋白，163.361 mg/L；hs-CRP，0.196 mg/L；血清白蛋白，55.966 g/L。该模型对早期CRC的敏感性（95.45%，95%CI 87.2 - 98.6%）高于晚期CRC（87.27%，95%CI 76.4 - 93.5%；P = 0.08）。受试者工作特征曲线下面积（AUC）在训练队列中为0.907，在验证队列中为0.872。该模型对早期CRC的敏感性（95.45%）高于晚期CRC（87.27%），突出了其在早期检测中的实用性。
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