RecruitingNCT07392567

Prospective Validation of an AI Model for Predicting Liver Metastasis in Colorectal Cancer

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

Sponsor

Tongji Hospital

Enrollment

160 participants

Start Date

Jan 30, 2026

Study Type

OBSERVATIONAL

Conditions

Colorectal Cancer Liver Metastasis

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether an AI (artificial intelligence) model can accurately predict which patients with colon or rectal cancer will develop liver metastasis (cancer spreading to the liver) after surgery. The model uses CT scan images taken before surgery to make its predictions. This is an observational study — your treatment is not changed. **You may be eligible if...** - You are 18 to 75 years old - You have been diagnosed with primary colon or rectal cancer (stage I–III) and are scheduled for curative surgery - You have had a contrast-enhanced CT scan of your abdomen and pelvis within the past month - There is no evidence of cancer spread to the liver or other distant sites before surgery - Your general health is good (ECOG 0 or 1) **You may NOT be eligible if...** - Your cancer has already spread to the liver or other organs - Your surgery did not fully remove the cancer (non-R0 resection) - You have a different type of cancer (not adenocarcinoma) - Your CT scan quality is not adequate for the AI model Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTMultimodal Deep Learning Prediction Model

This is a non-therapeutic, prognostic study. The intervention under investigation is the application of a pre-specified multimodal deep learning model that integrates preoperative CT imaging, digital pathology, and clinical data to stratify patients' risk of developing metachronous liver metastasis. This model functions as a prognostic tool and is not used to guide patient management in this study. Its performance is being evaluated prospectively against the actual clinical outcomes.

Locations(1)

Tongji Hospital

Wuhan, Hubei, China

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NCT07392567

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