A Multicenter, Retrospective, Observational Study to Develop and Validate a Multimodal Deep Learning Model for Predicting Metachronous Liver Metastasis in Colorectal Cancer Patients After Curative Resection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Area Under the Receiver Operating Characteristic Curve (AUC)
研究概览
简要总结
This multicenter, retrospective study aims to develop and validate a multimodal deep learning model for predicting the risk of metachronous liver metastasis in patients with stage I-III colorectal cancer following curative resection. The model will integrate preoperative contrast-enhanced CT imaging, digitized histopathological whole-slide images, and standard clinical-pathological data.
The primary objective is to assess the model's discriminatory performance, measured by the area under the receiver operating characteristic curve (AUC), and to compare its predictive accuracy against traditional prognostic factors such as TNM staging and serum carcinoembryonic antigen levels. This research utilizes existing archival data; no direct patient contact or intervention is involved. The ultimate goal is to provide a robust, data-driven tool for improved risk stratification, which could potentially guide personalized surveillance strategies and adjuvant therapy decisions in the future.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years, any gender.
- •Histologically confirmed primary colon or rectal adenocarcinoma.
- •Underwent curative radical resection (R0 resection) for colorectal cancer.
- •Preoperative contrast-enhanced abdominal/pelvic CT scan performed within 1 month before surgery, with acceptable image quality.
- •No evidence of distant metastasis (including synchronous liver metastasis) on preoperative or intraoperative exploration.
排除标准
- •History of other malignant tumors.
- •Previous history of liver surgery or liver transplantation.
- •Missing clinical, imaging, or pathological data required for the study.
- •Death within the perioperative period (within 30 days after surgery).
- •Lack of regular follow-up information.
研究组 & 干预措施
Colorectal Cancer Resection Cohort
A retrospective cohort of adult patients (aged 18-75) with stage I-III primary colorectal adenocarcinoma who underwent curative (R0) resection. This cohort is defined for the purpose of developing and validating a multimodal deep learning model to predict the risk of metachronous liver metastasis. All data, including preoperative contrast-enhanced CT scans, postoperative digitized pathology slides, and clinical records, were collected retrospectively from routine clinical practice. No interventions were administered as part of this study.
干预措施: Multimodal Deep Learning Model Analysis (Other)
结局指标
主要结局
Area Under the Receiver Operating Characteristic Curve (AUC)
时间窗: up to 3 years
The discriminatory performance of the multimodal deep learning model for predicting the 3-year risk of metachronous liver metastasis. The model integrates preoperative contrast-enhanced CT images, digitized whole-slide pathology images, and clinical data. The AUC will be calculated on the held-out independent test set. The assessment is based on data collected from the date of curative surgery (baseline) to the date of first imaging-confirmed liver metastasis or last follow-up.
次要结局
- Liver Metastasis-Free Survival (LMFS) by Risk Group(up to 3 years)