Clinical trial · Observational
Deep Learning-Based Analysis of Colorectal Cancer Pathology Images: An Innovative Approach for Predicting Colorectal Cancer Subtypes
AI-Powered Copilots for Precision Diagnosis and Surgical Assessment of Histological Growth Patterns in Resectable Colorectal Liver Metastases: A Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Artificial Intelligence (AI) in Diagnosis | — | UNRESOLVED | — |
| Colorectal Liver Metastasis (CRLM) | — | UNRESOLVED | — |
| Desmoplastic Classification | — | UNRESOLVED | — |
| Histopathological Growth Patterns (HGPs) | — | UNRESOLVED | — |
| Vision Transformer (ViT) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CRLM surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Surgical pathology slides from the SAHSYSU, 1,994 WSIs from 297 slides dated July 3, 2013.
- description
- This group includes 297 patients with colorectal cancer liver metastasis (CRLM), from which 1,994 whole slide images (WSIs) were collected. These slides were used for developing and testing the COFFEE AI model for histopathological growth pattern (HGP) classification, providing valuable insights for tumor characterization and prognosis.
- interventionNames
- Procedure: CRLM surgery
- label
- Surgical pathology slides from the SAHSYSU , 972 WSIs from 104 patients dated April 21, 2023.
- description
- This cohort contains 104 patients diagnosed with CRLM. 972 WSIs were collected to validate the COFFEE model on a more recent dataset, evaluating the model's performance in both binary and four-class HGP classifications.
- interventionNames
- Procedure: CRLM surgery
- label
- Surgical pathology slides from the SAHSYSU, 114 WSIs from 30 patients dated 2024.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients diagnosed with colorectal cancer liver metastasis (CRLM) undergoing surgical treatment; 2. The maximum diameter of resected metastatic lesions should be ≥ 2 cm; 3. Availability of pathology slides along with baseline clinical, biological, and pathological features. Exclusion Criteria: 1. Tissue sections obtained from biopsy specimens; 2. Absence of viable tumor tissue in metastatic lesions; 3. Lesions previously treated with ablation followed by surgical resection, resulting in inadequate tissue slide quality.
References
Publications (0)
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