Zhu Cheng, Zhang Nenghua, Zhong Ailing, Xiao Kangjia, Lu Renquan, Guo Lin
Department of Clinical Laboratory, Fudan University Shanghai Cancer Center, Shanghai, China.
Department of Clinical Laboratory, Municipal Key-Innovative Discipline of Molecular Diagnostics, Jiaxing Hospital of Traditional Chinese Medicine, Jiaxing, China.
Clin Chim Acta. 2022 Jan 1;524:43-50. doi: 10.1016/j.cca.2021.11.018. Epub 2021 Nov 20.
The dual marker algorithm Risk of Ovarian Malignancy Algorithm (ROMA) has been widely used in the clinic for the identification of equivocal pelvic masses in ovarian carcinoma. To obtain higher diagnostic efficiency, we created a new diagnostic index, Risk of Ovarian Malignancy Index (ROMI), by combing thymidine kinase 1 (TK1), HE4 and CA125.
335 patients with pelvic masses on imaging and 46 healthy controls were enrolled. Serum TK1 was analyzed before further study. ROMI and ROMA were evaluated for diagnostic efficiency.
The level of TK1 was elevated in malignant ovarian tumors compared to benign masses (p < 0.001) and healthy controls (p < 0.001). TK1 expression was positively correlated with stage, intrapelvic metastasis, lymphatic metastasis and distant metastasis (all p values < 0.001). The area under the receiver operating characteristic curve (AUC) of ROMI was higher than that of ROMA for both pre- and postmenopausal women. ROMI had better sensitivity, specificity, accuracy, and positive and negative predictive values than ROMA in diagnosis of all-stage or stage I + II ovarian carcinoma for both pre- and postmenopausal women.
TK1 is a potential biomarker in detection of ovarian carcinoma. ROMI shows better diagnostic performance than ROMA in distinguishing malignant ovarian tumors from benign masses.
双标志物算法卵巢恶性肿瘤风险算法(ROMA)已在临床上广泛用于识别卵巢癌中模棱两可的盆腔肿块。为了获得更高的诊断效率,我们通过结合胸苷激酶1(TK1)、人附睾蛋白4(HE4)和癌抗原125(CA125)创建了一种新的诊断指标——卵巢恶性肿瘤风险指数(ROMI)。
纳入335例影像学检查发现盆腔肿块的患者和46例健康对照者。在进一步研究前分析血清TK1。评估ROMI和ROMA的诊断效率。
与良性肿块(p < 0.001)和健康对照者(p < 0.001)相比,恶性卵巢肿瘤中TK1水平升高。TK1表达与分期、盆腔内转移、淋巴转移和远处转移呈正相关(所有p值< 0.001)。绝经前和绝经后女性中,ROMI的受试者工作特征曲线下面积(AUC)均高于ROMA。在诊断绝经前和绝经后女性的全期或Ⅰ + Ⅱ期卵巢癌时,ROMI在敏感性、特异性、准确性以及阳性和阴性预测值方面均优于ROMA。
TK1是检测卵巢癌的潜在生物标志物。在区分恶性卵巢肿瘤与良性肿块方面,ROMI的诊断性能优于ROMA。