Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT07027605
Status:
RECRUITING
Last Update Posted:
2025-08-19
First Post:
2025-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multi-Reader Multi-Case Trial Evaluating Computer-Aided Tool for Prognostic Prediction of Colorectal Liver Metastases
Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
This study aims to evaluate the impact of a novel computer-aided prognostic prediction tool on clinician performance in managing patients with colorectal liver metastases (CRLM). Colorectal cancer remains one of the leading causes of cancer-related mortality worldwide, with approximately 20-30% of patients presenting synchronous liver metastases at diagnosis. These metastases are associated with poor prognosis and a high rate of postoperative recurrence.
For selected patients, simultaneous resection of the primary colorectal tumor and liver metastases is the preferred treatment approach, though clinical outcomes vary widely. To address this variability, the latest web-based prediction tool employs Random Forest machine learning models that integrate comprehensive demographic, clinical, laboratory, and genetic data. This tool is specifically designed to predict postoperative recurrence and mortality for CRLM patients undergoing simultaneous resection, enabling individualized risk assessment.
In this multiple-reader, multiple-case (MRMC) study, 12 physicians will independently evaluate 166 retrospective patient cases. Each physician will estimate the risk of disease recurrence and mortality at 1-, 3-, and 5-year time points, both with and without access to the prediction tool. These two assessment phases will be separated by a washout period to minimize bias.
The primary objective is to determine whether use of the tool improves the accuracy of predicting 3-year postoperative mortality, quantified by the area under the receiver operating characteristic curve (AUC-ROC). Secondary and exploratory endpoints include prediction accuracy at other time points, sensitivity, specificity, inter-rater reliability, clinician confidence in decision-making, and time required for evaluation.
By providing specific, data-driven risk estimates, this computer-aided prognostic tool aims to enhance clinical decision-making and support personalized treatment planning for CRLM patients undergoing simultaneous resection, ultimately striving to improve patient outcomes.
For selected patients, simultaneous resection of the primary colorectal tumor and liver metastases is the preferred treatment approach, though clinical outcomes vary widely. To address this variability, the latest web-based prediction tool employs Random Forest machine learning models that integrate comprehensive demographic, clinical, laboratory, and genetic data. This tool is specifically designed to predict postoperative recurrence and mortality for CRLM patients undergoing simultaneous resection, enabling individualized risk assessment.
In this multiple-reader, multiple-case (MRMC) study, 12 physicians will independently evaluate 166 retrospective patient cases. Each physician will estimate the risk of disease recurrence and mortality at 1-, 3-, and 5-year time points, both with and without access to the prediction tool. These two assessment phases will be separated by a washout period to minimize bias.
The primary objective is to determine whether use of the tool improves the accuracy of predicting 3-year postoperative mortality, quantified by the area under the receiver operating characteristic curve (AUC-ROC). Secondary and exploratory endpoints include prediction accuracy at other time points, sensitivity, specificity, inter-rater reliability, clinician confidence in decision-making, and time required for evaluation.
By providing specific, data-driven risk estimates, this computer-aided prognostic tool aims to enhance clinical decision-making and support personalized treatment planning for CRLM patients undergoing simultaneous resection, ultimately striving to improve patient outcomes.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: