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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorTongji Hospital

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Multimodal Deep Learning Prediction Model

Treatment groups

160 Participants
are divided into 1 treatment group

Sponsors and collaborators