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RECRUITING
NCT07392567

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

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

160

Start Date

2026-01-30

Completion Date

2029-01-30

Last Updated

2026-02-06

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Multimodal 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