Department of Gastrointestinal Surgery, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.
Department of Gastrointestinal Surgery, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China
BMJ Open. 2024 Oct 1;14(10):e083659. doi: 10.1136/bmjopen-2023-083659.
Gastric cancer (GC) is the fourth leading cause of cancer mortality worldwide. Peritoneal metastasis (PM) is a significant cause of death in patients with GC, and presents a major challenge in clinical diagnosis and treatment. Predicting the occurrence of PM in high-risk patients, and diagnosing and treating PM in advance to improve patient survival, remains an unsolved problem in clinical practice. Given the low positive rate of cytology and difficulty in diagnosing occult PM, new molecular markers and detection technologies for early diagnosis require urgent validation. The primary objective of this study is to observe and evaluate the predictive effect of intraoperative peritoneal lavage fluid (PLF) circulating tumour cells (CTC) and circulating tumour DNA (ctDNA) levels in patients with pT4NxM0/pT1-3N+M0 GC on metachronous PM after R0 resection.
This prospective single-centre clinical study is conducted at Renji Hospital, Shanghai Jiao Tong University School of Medicine. In this study, 200 cases of patients with pT4NxM0/pT1-3N+M0 gastric adenocarcinoma older than 18 years will be screened. Participants will undergo intraoperative PLF CTC and ctDNA testing and will be followed up for 2 years, with imaging assessments performed every 3-6 months until PM occurrs. The primary outcome is the incidence of PM 1 year after surgery, which will be estimated using Clopper-Pearson method, with 95% CIs calculated and compared between groups. Secondary outcome include the incidence of PM 2 years after surgery, overall survival and disease progression. Data will be analysed using the Kaplan-Meier method and the log-rank test.
Informed consent has been obtained from all subjects. This protocol has been approved by the Ethics Committee of Renji Hospital, Shanghai Jiao Tong University School of Medicine (LY2023-142-B). The findings will be disseminated through peer-reviewed manuscripts, reports and presentations.
ChiCTR2300074910.
胃癌（GC）是全球第四大癌症死亡原因。腹膜转移（PM）是 GC 患者死亡的重要原因，也是临床诊断和治疗的主要挑战。在高危患者中预测 PM 的发生，并提前诊断和治疗 PM，以提高患者的生存率，这在临床实践中仍然是一个未解决的问题。鉴于细胞学的阳性率低，以及隐匿性 PM 的诊断困难，新的分子标志物和检测技术用于早期诊断需要紧急验证。本研究的主要目的是观察和评估术中腹膜灌洗液（PLF）循环肿瘤细胞（CTC）和循环肿瘤 DNA（ctDNA）水平在 pT4NxM0/pT1-3N+M0 GC 患者 R0 切除术后发生异时性 PM 的预测效果。
这是一项在上海交通大学医学院仁济医院进行的前瞻性单中心临床研究。在这项研究中，将筛选 200 例年龄大于 18 岁的 pT4NxM0/pT1-3N+M0 胃腺癌患者。参与者将接受术中 PLF CTC 和 ctDNA 检测，并进行为期 2 年的随访，每 3-6 个月进行一次影像学评估，直到 PM 发生。主要结局是术后 1 年 PM 的发生率，将使用 Clopper-Pearson 方法进行估计，并计算和比较组间的 95%置信区间。次要结局包括术后 2 年 PM 的发生率、总生存率和疾病进展。数据将使用 Kaplan-Meier 方法和对数秩检验进行分析。
所有受试者均已获得知情同意。本方案已获得上海交通大学医学院仁济医院伦理委员会的批准（LY2023-142-B）。研究结果将通过同行评议的论文、报告和演讲进行传播。
ChiCTR2300074910。
