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临床试验/NCT06663852
NCT06663852已完成不适用

Machine Learning-Based Decision Model for Optimal Adjuvant Therapy in Primary Gastric Neuroendocrine Carcinoma: a National Real-World Evidence Study

Chang-Ming Huang, Prof.1 个研究点 分布在 1 个国家目标入组 1,505 人开始时间: 2024年1月1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
1,505
试验地点
1
主要终点
Disease-Free Survival (DFS)

研究概览

简要总结

Gastric neuroendocrine carcinoma (G-NEC) is a rare and aggressive tumor originating from neuroendocrine cells in the stomach lining. It is characterized by a high propensity for recurrence and a generally poor prognosis. Due to its rarity, there is limited data and no established consensus on the optimal postoperative adjuvant therapy, making treatment decisions challenging for healthcare providers.

This study is a retrospective analysis focusing on evaluating survival rates, identifying prognostic factors, and formulating treatment recommendations for patients with G-NEC. By analyzing real-world clinical data, we aim to better understand the factors that influence patient outcomes and to develop evidence-based strategies for improving survival. Our goal is to provide clinicians with valuable insights and tools to make more informed treatment decisions, ultimately enhancing the quality of care and outcomes for patients with this challenging disease.

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

入选标准

  • (1) patients who underwent radical surgery without any neoadjuvant therapy;
  • (2) pathology confirmed NEC or mixed adenoneuroendocrine carcinoma (MANEC).

排除标准

  • (1) history of other malignant neoplasms;
  • (2) treatment with endoscopic submucosal dissection or endoscopic mucosal resection or thoracotomy;
  • (3) incomplete clinical data (including pathological, adjuvant chemotherapy, and follow-up information);
  • (4) receipt of alternative adjuvant treatment regimens;
  • (5) death within 30 days postoperatively.

结局指标

主要结局

Disease-Free Survival (DFS)

时间窗: From date of surgery up to 5 years

Disease-free survival is defined as the time from the date of surgery to disease recurrence, death from any cause, or last follow-up, whichever occurs first. The machine learning model's performance in predicting DFS and recommending optimal adjuvant therapy will be evaluated.

次要结局

未报告次要终点

研究者

发起方
Chang-Ming Huang, Prof.
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Chang-Ming Huang, Prof.

Prof.

Fujian Medical University

研究点 (1)

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