Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.
Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
BMC Cancer. 2020 Feb 21;20(1):138. doi: 10.1186/s12885-020-6630-0.
To study the kinetic profile and clinicopathological implications of squamous cell carcinoma antigen (SCC-Ag) in cervical cancer patients who underwent surgery by a self-developed SCC-Ag single molecule assay (Simoa) prototype immunoassay.
Participants were prospectively enrolled between 04/2016 and 06/2017. Consecutive serum samples were collected at five points: day 0 (the day before surgery), postoperative day 4, weeks 2-4, months 2-4 and months 5-7. In total, 92 patients and 352 samples were included. The kinetic change in SCC-Ag levels and their associations with clinicopathological characteristics were studied.
Simoa SCC-Ag was validated by comparison with the Architect assay. SCC-Ag levels measured by the Simoa assay were highly correlated with the Architect assay's levels (Pearson's correlation coefficient = 0.979, Passing-Bablok regression slope 0.894 (0.847 to 0.949), intercept - 0.009 (- 0.047 to 0.027)). The median values for each time-point detected by the Simoa assay were 2.49, 0.66, 0.61, 0.72, and 0.71 ng/mL, respectively. The SCC-Ag levels decreased dramatically after surgery and then stabilized and fluctuated to some extent within 6 months. Patients with certain risk factors had significantly higher SCC-Ag values than their negative counterparts before surgery and at earlier time points after surgery, while no difference existed at the end of observation. Furthermore, although patients with positive lymph nodes had sustained higher SCC-Ag levels compared to those with negative lymph nodes, similar kinetic patterns of SCC-Ag levels were observed after surgery. Patients who received postoperative treatment had significantly higher SCC-Ag values than those with surgery only at diagnosis, while no difference existed after treatment.
The Simoa SCC-Ag prototype was established for clinical settings. The SCC-Ag levels were higher in patients with risk factors, whereas the kinetic trend of SCC-Ag might be mainly affected by postoperative adjuvant therapy. These data indicate that the SCC-Ag level might be a good predictor for the status of cervical cancer, including disease aggressiveness and treatment response.
本研究旨在通过自行开发的鳞状细胞癌抗原（SCC-Ag）单分子检测（Simoa）原型免疫分析法，研究手术治疗宫颈癌患者的 SCC-Ag 动力学特征及其与临床病理特征的关系。
本研究为前瞻性队列研究，于 2016 年 4 月至 2017 年 6 月期间连续纳入患者。共采集了 5 个时间点的连续血清样本：术前 1 天（第 0 天）、术后第 4 天、术后 2-4 周、2-4 个月和 5-7 个月。共纳入 92 例患者和 352 个样本。研究 SCC-Ag 水平的变化及其与临床病理特征的关系。
通过与 Architect 检测方法比较，验证了 Simoa SCC-Ag 的准确性。Simoa 检测方法测定的 SCC-Ag 水平与 Architect 检测方法高度相关（Pearson 相关系数=0.979，Passing-Bablok 回归斜率 0.894（0.847 至 0.949），截距-0.009（-0.047 至 0.027））。Simoa 检测方法检测到的各时间点的中位数分别为 2.49、0.66、0.61、0.72 和 0.71ng/ml。术前和术后较早时间点，具有某些危险因素的患者 SCC-Ag 值明显高于无危险因素的患者，而在观察结束时则无差异。此外，尽管淋巴结阳性患者的 SCC-Ag 值持续高于淋巴结阴性患者，但术后 SCC-Ag 值的变化趋势相似。与仅接受手术治疗的患者相比，接受术后治疗的患者在诊断时的 SCC-Ag 值明显更高，但治疗后则无差异。
该研究建立了 Simoa SCC-Ag 的临床检测方法。具有危险因素的患者 SCC-Ag 值较高，而 SCC-Ag 的动力学趋势可能主要受术后辅助治疗的影响。这些数据表明，SCC-Ag 水平可能是宫颈癌状态的良好预测指标，包括疾病侵袭性和治疗反应。
