NCT07027605 Multi-Reader Multi-Case Trial Evaluating Computer-Aided Tool for Prognostic Prediction of Colorectal Liver Metastases
| NCT ID | NCT07027605 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Colorectal Liver Metastasis (CRLM) |
| Study Type | OBSERVATIONAL |
| Enrollment | 166 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2025-09-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 166 participants in total. It began in 2025-01-01 with a primary completion date of 2025-09-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * ≥ 18 years old * confirmation of histologically diagnosed liver metastases of colorectal adenocarcinoma * receiving colorectal resection with simultaneous liver resection. Exclusion Criteria: * 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.
Contact & Investigator
Hong Zhao, MD
PRINCIPAL INVESTIGATOR
Cancer Hospital Chinese Academy of Medical Science
Frequently Asked Questions
Who can join the NCT07027605 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Liver Metastasis (CRLM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07027605 currently recruiting?
Yes, NCT07027605 is actively recruiting participants. Contact the research team at zhaohong@cicams.ac.cn for enrollment information.
Where is the NCT07027605 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07027605 clinical trial?
NCT07027605 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The principal investigator is Hong Zhao, MD at Cancer Hospital Chinese Academy of Medical Science. The trial plans to enroll 166 participants.