Multi-Reader Multi-Case Trial Evaluating Computer-Aided Tool for Prognostic Prediction of Colorectal Liver Metastases

Recruiting now

Conditions studied: Colorectal Liver Metastasis (CRLM)

In brief

This study evaluates the impact of a novel computer-aided prognostic prediction tool for colorectal liver metastases (CRLM) on clinician performance. Colorectal cancer is a leading cause of cancer-related mortality worldwide, with 20-30% of patients presenting synchronous liver metastases, which are associated with poor prognosis and high postoperative recurrence rates. Simultaneous resection of primary tumor and liver metastases is a preferred treatment for selected patients but outcomes vary significantly. The latest web-based tool uses Random Forest models integrating demographic, clinical, laboratory, and genetic data to predict postoperative recurrence and mortality specifically for CRLM patients undergoing simultaneous resection. This multiple-reader, multiple-case (MRMC) study will assess 12 physicians who will predict 1-, 3-, and 5-year recurrence and mortality risks in 166 retrospective cases, with and without the tool's aid, separated by a washout period. The primary focus is to determine whether the tool improves prediction accuracy for 3-year postoperative mortality, measured by AUC-ROC. Secondary and exploratory endpoints include other time points, sensitivity, specificity, inter-rater reliability, decision-making confidence, and evaluation time. By enabling individualized risk assessment, this tool aims to support optimized clinical decision-making and tailored treatment strategies for CRLM patients undergoing simultaneous resection.

Key facts

Study ID

NCT07027605

Run by

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

People needed

166

Starts

2025-01-01

Expected to finish

2025-09-25

Last updated by the study team

2025-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years old
• confirmation of histologically diagnosed liver metastases of colorectal adenocarcinoma
• receiving colorectal resection with simultaneous liver resection.

You may not qualify if…

• presence of other malignancies
• absence of follow-up data
• patients who were followed up postoperatively for less than 5 years and had no occurrences of death.

Where it is running

• No. 17, South Panjiayuan, Chaoyang District, Beijing, Cancer Hospital, Chinese Academy of Medical Sciences, China — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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