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

Recruitingn/aAges 18 Years - 75 YearsAllTongji Hospital
NCT07392567 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 metastas

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📋 Eligibility rules (as published)
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.
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What it tests

  • Multimodal Deep Learning Prediction Model
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Where

1 site
Tongji Hospital
Wuhan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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