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Clinical Trials in China / NCT07392567
Recruiting Observational

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

NCT07392567 · tracked via the Priya Life Science China tracker
Sponsor
Tongji Hospital
Phase
Observational
Started
2026-01-30
Last updated
2026-02-06

Condition(s) studied

Colorectal Cancer Liver Metastasis

Investigational drug(s) / intervention(s)

Multimodal Deep Learning Prediction Model

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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 1. * Patient or their legal representative voluntarily participates and provides written informed consent. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Tongji Hospital Wuhan Hubei Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07392567 on ClinicalTrials.gov ↗ ← All trials in China