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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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 criteria

Qualifiers

≥ 18 years old

confirmation of histologically diagnosed liver metastases of colorectal adenocarcinoma

receiving colorectal resection with simultaneous liver resection.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

166 Participants
are grouped into 2 trial groups