Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT07392567

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

Led by Tongji Hospital · Updated on 2026-02-06

160

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years, any gender
  • Clinical diagnosis of primary colon or rectal adenocarcinoma (Stage I-III)
  • Scheduled for curative radical resection of colorectal cancer
  • Preoperative contrast-enhanced abdominal/pelvic CT scan within 1 month before surgery with acceptable image quality
  • No distant metastasis including synchronous liver metastasis on preoperative examination
  • ECOG Performance Status of 0 or 1
  • Voluntary participation with signed informed consent
Not Eligible

You will not qualify if you...

  • Postoperative pathology confirms non-primary colorectal adenocarcinoma or presence of distant metastasis
  • Intraoperative finding of non-R0 resection or only palliative surgery/ostomy performed
  • History of other malignant tumors
  • Previous liver surgery or liver transplantation
  • Death within 30 days after surgery
  • Refusal to participate in follow-up, withdrawal of consent, or lost to follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Tongji Hospital

Wuhan, Hubei, China

Actively Recruiting

Loading map...

Research Team

Y

Yang WU, M.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here