Background and Aim. This exploratory study explored single-stranded DNA (ssDNA) for hepatocellular carcinoma (HCC) diagnosis and prognosis. Methods. This prospective study enrolled 102 patients with newly diagnosed HCC, 21 with cirrhosis, 20 with chronic hepatitis, 284 with nonliver diseases, and 45 healthy individuals at the Affiliated Wuxi No. 2 People’s Hospital of Nanjing Medical University (May-October 2018). ssDNA was extracted using magnetic beads and quantified using the Qubit ssDNA assay. ssDNA levels were compared among the disease groups and in HCC vs. non-HCC. Receiver operating characteristic (ROC) curves were used to determine the diagnostic value of ssDNA. In patients with resectable HCC, ssDNA and α-fetoprotein (AFP) levels were measured during follow-up and compared with HCC recurrence detected by imaging. Results. The median ssDNA levels were higher in HCC than in healthy individuals, cirrhosis, and chronic hepatitis (median, 23.20 vs. 9.36, 9.64, and 9.76 ng/μL, respectively, ). ssDNA levels in HCC were higher than those in cirrhosis and chronic hepatitis (both ); there were no differences in ssDNA levels between healthy controls and patients with cirrhosis () or chronic liver disease (). The area under the curve of ssDNA for HCC diagnosis was 0.909 (95% CI: 0.879-0.933). The ssDNA levels decreased by 3.19-fold () after HCC radical resection. In six patients, the ssDNA levels increased about 3-6 months before a recurrence was detected by AFP and imaging. Conclusions. ssDNA might be a noninvasive indicator for HCC diagnosis and prognosis. ssDNA could eventually be complementary to AFP levels and imaging, but confirmatory studies are necessary.

中文翻译：

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ssDNA 作为非侵入性指标在肝细胞癌诊断和预后中的作用：一项探索性研究

背景和目的。这项探索性研究探索了用于肝细胞癌 (HCC) 诊断和预后的单链 DNA (ssDNA)。方法。这项前瞻性研究在南京医科大学附属无锡市第二人民医院（2018年5月-10月）入组了102例新诊断的HCC患者、21例肝硬化患者、20例慢性肝炎患者、284例非肝病患者和45例健康人。使用磁珠提取 ssDNA 并使用 Qubit ssDNA 测定法进行量化。比较疾病组和 HCC 与非 HCC 的 ssDNA 水平。受试者工作特征（ROC）曲线用于确定 ssDNA 的诊断价值。在可切除 HCC 患者中，ssDNA 和α在随访期间测量了甲胎蛋白 (AFP) 水平，并与通过成像检测到的 HCC 复发进行比较。结果。HCC 的中位 ssDNA 水平高于健康个体、肝硬化和慢性肝炎（中位值分别为 23.20 和 9.36、9.64 和 9.76 ng/ μL，）。HCC 的 ssDNA 水平高于肝硬化和慢性肝炎（均); 健康对照组和肝硬化患者的 ssDNA 水平没有差异（)或慢性肝病 (）。ssDNA诊断HCC的曲线下面积为0.909（95% CI：0.879-0.933）。ssDNA 水平下降了 3.19 倍（) HCC 根治性切除术后。在 6 名患者中，ssDNA 水平在 AFP 和成像检测到复发前约 3-6 个月增加。结论。ssDNA 可能是 HCC 诊断和预后的非侵入性指标。ssDNA 最终可能与 AFP 水平和成像互补，但验证性研究是必要的。