AI-Powered Copilots for Precision Diagnosis and Surgical Assessment of Histological Growth Patterns in Resectable Colorectal Liver Metastases: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 431
- 试验地点
- 1
- 主要终点
- Classification Accuracy (%) of the COFFEE AI Model in Binary Identification of Histopathological Growth Patterns (HGPs) in CRLM Using Whole Slide Images
研究概览
简要总结
Colorectal cancer (CRC) is a leading cause of mortality in China, with metastasis significantly contributing to poor outcomes. Histopathological growth patterns (HGPs) in colorectal liver metastasis (CRLM) provide vital prognostic insights, yet the limited number of pathologists highlights the need for auxiliary diagnostic tools. Recent advancements in artificial intelligence (AI) have demonstrated potential in enhancing diagnostic precision, prompting the development of specialized AI models like COFFEE to improve the classification and management of HGPs in CRLM patients. This study aims to develop and validate a Transformer-based deep learning model, COFFEE, for the classification of colorectal cancer subtypes using whole slide images (WSIs) from patients diagnosed with colorectal cancer liver metastasis. The model is pre-trained using self-supervised learning (DINO) on WSIs from the TCGA-COAD cohort, utilizing a Vision Transformer (ViT) architecture to extract 384-dimensional feature vectors from 256×256 pixel patches. The COFFEE model integrates a Transformer-based Multiple Instance Learning (TransMIL) framework, incorporating multi-head self-attention and Pyramid Position Encoding Generator (PPEG) modules to aggregate spatial and morphological information. The study includes training, testing, and prospective validation cohorts and evaluates the performance of the model in both binary and multi-class classification settings, as well as its potential to assist pathologists in clinical workflows.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients diagnosed with colorectal cancer liver metastasis (CRLM) undergoing surgical treatment;
- •The maximum diameter of resected metastatic lesions should be ≥ 2 cm;
- •Availability of pathology slides along with baseline clinical, biological, and pathological features.
排除标准
- •Tissue sections obtained from biopsy specimens;
- •Absence of viable tumor tissue in metastatic lesions;
- •Lesions previously treated with ablation followed by surgical resection, resulting in inadequate tissue slide quality.
结局指标
主要结局
Classification Accuracy (%) of the COFFEE AI Model in Binary Identification of Histopathological Growth Patterns (HGPs) in CRLM Using Whole Slide Images
时间窗: 6 months post-surgery (for prospective cohort)
This outcome measures the diagnostic classification accuracy of the COFFEE AI model in detecting histopathological growth patterns (HGPs) in patients with colorectal cancer liver metastasis (CRLM). Accuracy is defined as the proportion of correctly predicted HGP labels compared to the ground truth labels determined by consensus of expert pathologists. The analysis includes binary classification (desmoplastic vs. non-desmoplastic). Accuracy will be calculated as: Accuracy = Total number of predictions / Number of correct predictions×100%. The outcome will be assessed using digital whole slide images obtained from liver metastasis specimens collected during surgery. Model performance will be evaluated 6 months post-surgery in a prospective validation cohort.
次要结局
- Classification Accuracy (%) of the COFFEE AI Model in Multi-Class Identification of Histopathological Growth Patterns (HGPs) in CRLM Using Whole Slide Images(6 months post-surgery (for prospective cohort))
研究者
Yunfang Yu
Attending Physician
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
