跳至主要内容
临床试验/NCT06337279
NCT06337279已完成不适用

The Clinical Value of Systemic Oxidative Stress Score in Predicting Long-term Survival and Recurrence Risk in Gastric Cancer: A Multicenter Real-world Cohort Study

Fujian Medical University1 个研究点 分布在 1 个国家目标入组 3,820 人开始时间: 2022年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,820
试验地点
1
主要终点
5-year OS

研究概览

简要总结

The Systemic Oxidative Stress Score (SOSS) , a comprehensive score reflecting the oxidative stress conditions in the microenvironment, can independently and effectively predict tumor burden and long-term prognosis in GC patients. Nomograms based on SOSS provide a potential and promising model for risk stratification and guiding the implementation of treatment decisions.

详细描述

We retrospectively analyzed the clinical data of gastric cancer patients who underwent radical gastrectomy in three hospitals from January 2009 to June 2020. The data from one hospital were randomly divided into a training cohort and an internal validation cohort in a 7:3 ratio, while the data from the other two centers were used as an external validation cohort. In the training cohort, COX proportional risk models were employed to identify key indicators of SOSS and independent prognostic factors influencing patients' OS and DFS. Subsequently, based on the results of the multifactor COX analysis, two predictive models for OS and DFS were developed. The predictive efficacy, calibration, and clinical utility of the models were evaluated using ROC curves, calibration curves, and decision curves in the internal and external validation cohorts, respectively. Both models demonstrated good discriminative ability between postoperative survival and recurrence risk, outperforming TNM staging in terms of predictive accuracy.

研究设计

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

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •gastroscopic histopathological diagnosis of gastric adenocarcinoma; 2) radical gastrectomy for GC; 3) preoperative examination of oxidative indicators including Fbg, CHOL, ALB, TBIL, DBIL, and CR within seven days before surgery; and 4) the tumor did not invade neighboring organs or had no distant metastasis.

排除标准

  • •gastroscopic histopathological diagnosis of non-adenocarcinoma, 2) gastric stump cancer, 3) neoadjuvant chemotherapy, 4) other malignant diseases besides GC, 5) incomplete medical records, and 6) patients with GC lost to follow-up.

结局指标

主要结局

5-year OS

时间窗: 5 years or 60 months

Overall survival, death, survival with tumor, deletion.

5-year DFS

时间窗: 5 years or 60 months

Disease-free survival, death,recurrence

次要结局

未报告次要终点

研究者

发起方
Fujian Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chang-Ming Huang, Prof.

Professor

Fujian Medical University

研究点 (1)

Loading locations...

相似试验