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

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

Recruiting
18-75 years
All
Phase N/A

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Overview

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

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.

Study details
    Colorectal Cancer Liver Metastasis

NCT07392567

Tongji Hospital

26 February 2026

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