An Artificial Intelligence - Assisted Model for Predicting Optimal Timing of Surgery in Advanced Ovarian Cancer: the Combined Study of the SUNNY Trial and the Real World Data
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,025
- 主要终点
- The accuracy of predicting the 3-year overall survival (OS) difference between primary debulking surgery (PDS) and interval debulking surgery (IDS).
研究概览
简要总结
This study integrates data from the randomized controlled SUNNY trial (RCT) and real-world (RWD) data, and employs multimodal data fitting to construct a medical artificial intelligence model to identify the clinical characteristics of patient subgroups suitable for primary debulking surgery (PDS) or interval debulking surgery (IDS), and the cutoff values for selecting different timings of surgery for advanced ovarian cancer.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patients who were included in the SUNNY study or who were newly diagnosed with stage IIIC or IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer during the SUNNY study period (2015-2023)
- •Underwent primary debulking surgery or interval debulking surgery
- •Data avaliable on first-line treatment and follow-up
排除标准
- •Non-epithelial ovarian cancer or borderline tumors.
- •Low-grade tumors.
- •Mucinous ovarian cancer.
- •Missing data on first-line treatment and follow-up
研究组 & 干预措施
Cohort 2- Pragmatic Trial
536 patients who were newly diagnosed as stage IIIC or IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer between 2021 and 2025
Cohort 1- SUNNY RCT Trial
489 patients who were enrolled and randomized in the SUNNY RCT trials.
结局指标
主要结局
The accuracy of predicting the 3-year overall survival (OS) difference between primary debulking surgery (PDS) and interval debulking surgery (IDS).
时间窗: 3 years
次要结局
未报告次要终点