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临床试验/NCT07096947
NCT07096947已完成不适用

A Multifactor Prediction Model for Non-curative Outcomes in Mixed-type Early Gastric Cancer: a Retrospective Cohort Study

The First Affiliated Hospital of Nanchang University1 个研究点 分布在 1 个国家目标入组 421 人开始时间: 2017年1月18日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
421
试验地点
1
主要终点
The incidence of adverse postoperative prognosis in patients with mixed-type early gastric cancer

研究概览

简要总结

The goal of this dual-center study is to identify the most valuable predictive factors (MVPs) for non-curable mixed-type early gastric cancer (NC-MTEGC) and develop a nomogram scoring model to assist surgeons in formulating precise postoperative combined radiochemotherapy strategies in patients with mixed-type early gastric cancer (MTEGC) who have undergone radical surgical resection. The main question it aims to answer is:

What are the most valuable predictive factors for NC-MTEGC, and can a nomogram scoring model developed based on these factors effectively assist in formulating precise postoperative combined radiochemotherapy strategies?

Patients with MTEGC who have undergone radical surgical resection (including 160 in the training group, 151 in the internal validation set from the First Affiliated Hospital of Nanchang University, and 110 in the external test cohort from the Second Affiliated Hospital of Nanchang University) will be included in the study. The Least Absolute Shrinkage and Selection Operator (LASSO) algorithm will be used to assess key predictive indicators, a nomogram prediction model will be developed based on logistic regression, and an NC-MTEGC risk score model will be constructed. Meanwhile, the model's discriminatory ability, calibration, and clinical utility will be comprehensively validated across the three cohorts, with follow-up for relevant conditions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mixed-type early gastric cancer (MTEGC);
  • Receive a surgical procedure;
  • Complete preoperative data.

排除标准

  • Received neoadjuvant therapy;
  • History of gastrectomy;
  • Previous cancer or residual gastric cancer (GC);
  • Distant metastasis at diagnosis;
  • Incomplete preoperative data;
  • Undifferentiated MTEGC components;
  • Missing imaging data or refusal of follow-up.

结局指标

主要结局

The incidence of adverse postoperative prognosis in patients with mixed-type early gastric cancer

时间窗: From enrollment to the end of treatment at 5 years

Evaluate the incidence of adverse postoperative prognosis in patients with mixed-type early gastric cancer via the Nomogram model scoring.

次要结局

  • Pathological malignancy grade(Periprocedural)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lu Han

Principal Investigator

The First Affiliated Hospital of Nanchang University

研究点 (1)

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