A Multicenter, Prospective, Observational Study for the Validation of a Multimodal Deep Learning Model to Predict Metachronous Liver Metastasis in Patients With Colorectal Cancer After Curative Resection
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Area Under the Receiver Operating Characteristic Curve (AUC)
概览
简要总结
This is a prospective, multicenter, observational study designed to validate the predictive accuracy of a pre-developed multimodal deep learning model. The model integrates preoperative contrast-enhanced CT scans, digitized postoperative pathology images, and standard clinical data to estimate the risk of liver metastasis within two years after curative surgery in patients with stage I-III colorectal cancer.
The primary objective is to evaluate the model's performance in an independent, prospectively enrolled patient cohort. Participants will receive standard-of-care treatment according to clinical guidelines. The study involves no experimental interventions; it solely involves the collection and analysis of routinely generated clinical data. The goal is to assess the model's potential for clinical translation by providing a reliable tool for stratifying patients' risk of liver metastasis, which could inform personalized surveillance strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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.
- •Clinical diagnosis of primary colon or rectal adenocarcinoma (Stage I-III). Scheduled to undergo curative radical 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 examination.
- •ECOG Performance Status of 0 or
- •Patient or their legal representative voluntarily participates and provides written informed consent.
排除标准
- •Postoperative pathological confirmation of non-primary colorectal adenocarcinoma or presence of distant metastasis.
- •Intraoperative determination of non-R0 resection, or performance of palliative surgery/ostomy only.
- •History of other malignant tumors.
- •Previous history of liver surgery or liver transplantation.
- •Death within the perioperative period (within 30 days after surgery).
- •Refusal to participate in follow-up, withdrawal of informed consent, or loss to follow-up.
研究组 & 干预措施
Prospective Validation Cohort
This single cohort consists of patients with stage I-III colorectal cancer who are prospectively enrolled after undergoing curative resection. No interventions are administered as part of this study. The cohort is used for the external validation of the pre-defined multimodal deep learning model's performance in predicting the risk of metachronous liver metastasis. All patients receive standard of care treatment and follow-up according to clinical guidelines.
干预措施: Multimodal Deep Learning Prediction Model (Diagnostic Test)
结局指标
主要结局
Area Under the Receiver Operating Characteristic Curve (AUC)
时间窗: 2 years after surgery
The discriminatory performance of the pre-specified multimodal deep learning model for predicting the occurrence of metachronous liver metastasis within 2 years after curative resection. The model integrates preoperative contrast-enhanced CT, digital pathology, and clinical data. Performance is evaluated on the entire prospectively enrolled validation cohort.
次要结局
- Liver Metastasis-Free Survival (LMFS) by Risk Group(From the date of surgery until the date of first documented liver metastasis or last follow-up, assessed up to 3 years.)