Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China
Actively Recruiting
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
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