A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Performance Improvement From Computer-aided Tool for the Prognostic Prediction of Colorectal Liver Metastases

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥ 18 years old

• confirmation of histologically diagnosed liver metastases of colorectal adenocarcinoma

• receiving colorectal resection with simultaneous liver resection.

Locations
Other Locations
China
No. 17, South Panjiayuan, Chaoyang District, Beijing, Cancer Hospital, Chinese Academy of Medical Sciences, China
RECRUITING
Beijing
Contact Information
Primary
HONG ZHAO, MD
zhaohong@cicams.ac.cn
+8613381106850
Backup
Qichen Chen, MD
chenqichen0822@126.com
+8618810550822
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2025-09-25
Participants
Target number of participants: 166
Treatments
Reader Group A: Interprets Dataset A in unaided scenario and Dataset B in aided scenario
A reader study with 12 readers (4 Junior Physician, 4 mid-level Physician and 4 Senior Physician) from the Department of Surgical Oncology of the Digestive Tract will be conducted. The readers are equally and randomly split between Group A and Group B. The study will target 166 CRLM patient cases receiving simultaneous resection.Patient cases will be equally and randomly split between Dataset A and Dataset B.
Reader Group B: Interprets Dataset A in aided scenario and Dataset B in unaided scenario
A reader study with 12 readers (4 Junior Physician, 4 mid-level Physician and 4 Senior Physician) from the Department of Surgical Oncology of the Digestive Tract will be conducted. The readers are equally and randomly split between Group A and Group B. The study will target 166 CRLM patient cases receiving simultaneous resection.Patient cases will be equally and randomly split between Dataset A and Dataset B.
Sponsors
Leads: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

This content was sourced from clinicaltrials.gov

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