Development and Validation of a Machine Learning Model for Predicting the Prognosis of Elderly Gastric Cancer Patients: A Multi-Center Study in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,202
- 试验地点
- 1
- 主要终点
- 5-Year Overall Survival
研究概览
简要总结
This study aims to develop and validate a Random Survival Forest (RSF) model for predicting long-term survival in elderly patients following curative resection for gastric cancer. The study is a retrospective multi-center analysis involving patients aged 75 and above who underwent gastric resection from January 2009 to December 2018 at nine top-tier hospitals in China. An online prognostic tool is introduced to assist clinicians in predicting patient prognosis and customizing treatment and follow-up strategies.
详细描述
This retrospective multi-center study focuses on the development and validation of a predictive model for elderly gastric cancer patients. Data were collected from 16,344 gastric cancer patients, with 1,202 elderly patients ultimately included after applying exclusion criteria. Patients were randomly divided into training and testing cohorts in a 7:3 ratio. The study was approved by the institutional review boards with a waiver of informed consent due to the use of anonymized secondary data.
The analysis employs the Random Survival Forest (RSF) method, incorporating variable importance and minimal depth techniques to select key variables for predicting overall survival (OS) and disease-free survival (DFS). The study also implements rigorous data handling procedures, including multiple imputations for missing data.
The development of an online prognostic tool based on the RSF model is part of the project, designed to provide real-time survival predictions through a user-friendly interface for clinical application.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 75 years or older.
- •Histologically confirmed diagnosis of gastric cancer.
- •Patients who have undergone curative gastrectomy.
排除标准
- •Patients with non-primary gastric malignancies.
- •Pathological confirmation of metastatic disease (M1).
- •Incomplete follow-up data or loss to follow-up.
结局指标
主要结局
5-Year Overall Survival
时间窗: 5 years or 60 months.
The proportion of patients who are alive at five years after treatment for elderly gastric cancer patients.
5-Year Disease-Free Survival
时间窗: 5 years or 60 months.
The proportion of patients who have survived without any signs or symptoms of gastric cancer for five years after the initial treatment.
次要结局
- 1-Year Overall Survival(1 years or 12 months.)
- 1-Year Disease-Free Survival(1 years or 12 months.)
- 3-Year Disease-Free Survival(3 years or 36 months.)
- 3-Year Overall Survival(3 years or 36 months.)
研究者
Chang-Ming Huang, Prof.
Professor
Fujian Medical University