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

Condition(s) studied

Study summary

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.

Eligibility

Primary outcome measure(s)

• AUCs: Area Under the Receiver Operating Characteristic Curve (AUC-ROC) — Up to approximately 120 months
  The comparative accuracy of model aided versus unaided risk prediction of post-operative 3-year mortality assessed by readers. Under model aided condition, prediction model will estimate the overall survival (OS) rate at Year 3 for each individual patient. OS was defined as the time from the date of simultaneous resection to death due to any cause. Patients without death were censored at their last known alive date. The mortality data were retrospectively collected and the event status were known. Patients were followed up to approximately 120 months after simultaneous resection.

Trial sites (1)

More Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials in China

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