Nomogram for prediction of prognosis in patients with initially unresectable colorectal liver metastases.
K Imai, M-A Allard, C Castro Benitez...
https://pubmed.ncbi.nlm.nih.gov/26780341Actively Recruiting
Age: 18Years +
All Genders
ID07027605
Multi-Reader Multi-Case Controlled Trial to Evaluate a Computer-Aided Tool for Prognostic Prediction in Colorectal Liver Metastases
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-08-19
166
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating a new computer-aided prognostic prediction tool designed to help doctors assess risks for patients with colorectal liver metastases (CRLM). Colorectal cancer is a major cause of cancer-related deaths worldwide, and 20-30% of patients have liver metastases at diagnosis, which often leads to poor outcomes and high recurrence after surgery. This study aims to see if the tool improves doctors' ability to predict postoperative recurrence and mortality for patients undergoing simultaneous resection of primary tumors and liver metastases. The study involves 12 physicians who will review 166 retrospective patient cases with CRLM. These doctors are split into two groups and will assess each case twice: once without the tool and once with the tool’s assistance, separated by a washout period. The tool uses Random Forest models combining demographic, clinical, laboratory, and genetic data to predict 1-, 3-, and 5-year risks of recurrence and death. The main goal is to measure improvement in prediction accuracy for 3-year postoperative mortality, with additional outcomes including accuracy at other times, sensitivity, specificity, consistency between doctors, confidence in decisions, and evaluation time. Participants in this study are the physicians who will use the tool to evaluate the cases. Researchers will analyze their predictions and compare performance with and without the tool. The study will measure outcomes using the area under the receiver operating characteristic curve (AUC-ROC) and other statistical tools over time. This observational study is conducted by the Cancer Institute and Hospital, Chinese Academy of Medical Sciences, and aims to support better personalized decision-making for CRLM patients undergoing surgery.
CONDITIONS
Brief Title
Multi-Reader Multi-Case Trial Evaluating Computer-Aided Tool for Prognostic Prediction of Colorectal Liver Metastases
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Histologically confirmed liver metastases from colorectal adenocarcinoma
- Receiving colorectal surgery with simultaneous liver resection
You will not qualify if you...
- Presence of other malignancies
- Lack of follow-up data
- Follow-up period less than 5 years after surgery with no death recorded
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Duration of assessment period
Physicians independently review retrospective patient cases to assess risk of disease recurrence and mortality.
2 separate assessment sessions with a washout period in between
Long-term Monitoring
Duration - Up to 5 years after surgery
Participants' data including postoperative recurrence and mortality are observed retrospectively up to 5 years after surgery.
No visits; retrospective data analysis
Trial Site Locations
Total: 1 location
1
No. 17, South Panjiayuan, Chaoyang District, Beijing, Cancer Hospital, Chinese Academy of Medical Sciences, China
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
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Research Team
H
HONG ZHAO, MD
Q
Qichen Chen, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Association of preoperative aspartate aminotransferase to platelet ratio index with outcomes and tumour microenvironment among colorectal cancer with liver metastases.
Qichen Chen, Yiqiao Deng, Yuan Li...
https://pubmed.ncbi.nlm.nih.gov/38458593Association of Simultaneous vs Delayed Resection of Liver Metastasis With Complications and Survival Among Adults With Colorectal Cancer.
Yibin Wu, Anrong Mao, Huipeng Wang...
https://pubmed.ncbi.nlm.nih.gov/36121654Correlation between recurrence-free survival and overall survival after upfront surgery for resected colorectal liver metastases.
Kozo Kataoka, Kanae Takahashi, Jiro Takeuchi...
https://pubmed.ncbi.nlm.nih.gov/37196147Simultaneous resection for colorectal cancer with synchronous liver metastases: current state-of-the-art.
Nikolaos Machairas, Marcello Di Martino, Florian Primavesi...
https://pubmed.ncbi.nlm.nih.gov/38583912Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.
Freddie Bray, Mathieu Laversanne, Hyuna Sung...
https://pubmed.ncbi.nlm.nih.gov/38572751Personalized prediction of postoperative complication and survival among Colorectal Liver Metastases Patients Receiving Simultaneous Resection using machine learning approaches: A multi-center study.
Qichen Chen, Jinghua Chen, Yiqiao Deng...
https://pubmed.ncbi.nlm.nih.gov/38768679