Prediction of Neoadjuvant Therapy Efficacy and Prognosis for Breast Cancer Based on Multimodal Data: A Multicenter Retrospective and Prospective Validation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,800
- 主要终点
- Predictive value of multimodal data for neoadjuvant therapy efficacy in breast cancer
研究概览
简要总结
This study aims to develop a multimodal deep learning model integrating MRI, ultrasound, digital pathology and clinical information based on multicenter retrospective data. To externally validate the model in an independent prospective cohort, and evaluate its accuracy in predicting pathological complete response (pCR), 3-year and 5-year disease-free survival (DFS). To establish visual tools such as nomograms, assisting clinicians in identifying patients with chemoresistance and facilitating individualized de-escalation or escalation treatment strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed invasive breast cancer;
- •Planned to receive a full course of neoadjuvant therapy;
- •Complete baseline imaging data (MRI/ultrasound/mammography) and core needle pathology results available.
排除标准
- •Previous history of ipsilateral breast cancer or chest radiotherapy;
- •Distant metastasis (Stage IV);
- •Poor image quality or missing clinical data exceeding 20%.
结局指标
主要结局
Predictive value of multimodal data for neoadjuvant therapy efficacy in breast cancer
时间窗: From enrollment to the end of surgery
Combined with preoperative multimodal MRI and ultrasound imaging parameters, pathological baseline data and clinical data, a prediction model for neoadjuvant therapy efficacy in breast cancer is constructed. Taking postoperative pathological response results as the evaluation basis, the predictive efficacy of multimodal data for neoadjuvant therapy complete response and non-complete response is evaluated.
次要结局
- Prognostic predictive value of multimodal data for breast cancer(From enrollment to the end of surgery)