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NCT Number: NCT07392567

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

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.

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Key information

Conditions

Colorectal Cancer Liver Metastasis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongji Hospital

Wuhan, Hubei, China

Location status: Recruiting

Location contact

Wanguang Zhang, M.D.

PRINCIPAL_INVESTIGATOR

Yang WU, M.D.

CONTACT

[email protected]

13636076910

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multimodal Deep Learning Prediction Model

Diagnostic Test

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.

Primary outcomes

  1. Area Under the Receiver Operating Characteristic Curve (AUC)

    Time frame: 2 years after surgery

    The discriminatory performance of the pre-specified multimodal deep learning model for predicting the occurrence of metachronous liver metastasis within 2 years after curative resection. The model integrates preoperative contrast-enhanced CT, digital pathology, and clinical data. Performance is evaluated on the entire prospectively enrolled validation cohort.

Secondary outcomes

  1. Liver Metastasis-Free Survival (LMFS) by Risk Group

    Time frame: From the date of surgery until the date of first documented liver metastasis or last follow-up, assessed up to 3 years.

    The difference in liver metastasis-free survival between the high-risk and low-risk groups, as stratified by the model. LMFS is defined as the time from surgery to the first radiological diagnosis of liver metastasis.

Study contacts

Contact information is provided by the study sponsor or research team.

Yang WU, M.D.

CONTACT

[email protected]

13636076910

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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