Computer-aided tool to predict outcomes after simultaneous colorectal and liver surgery
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
This project will test a web-based computer tool that helps doctors predict 1-, 3-, and 5-year recurrence and survival for adults with colorectal cancer who had liver metastases removed at the same time as their primary tumor.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 166 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07027605 on ClinicalTrials.gov |
What this trial studies
This multi-reader, multi-case observational study uses 166 retrospective patient cases to compare clinician predictions with and without a web-based Random Forest prognostic tool that integrates demographic, clinical, laboratory, and genetic data. Twelve physicians will independently estimate 1-, 3-, and 5-year recurrence and mortality risks for each case, with the two assessment rounds separated by a washout period. The primary analysis measures whether access to the tool improves accuracy of 3-year postoperative predictions. All cases are from patients who underwent simultaneous colorectal and liver resection at a single tertiary cancer center.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed colorectal adenocarcinoma liver metastases who underwent simultaneous resection of the primary tumor and liver lesions with adequate follow-up data are the cases used in this work.
Not a fit: Patients with other active malignancies, insufficient or missing follow-up data, or who did not have simultaneous colorectal and liver resection are unlikely to benefit from this tool.
Why it matters
Potential benefit: If successful, the tool could give doctors more accurate personalized estimates of recurrence and survival after simultaneous resection, helping guide treatment choices and follow-up planning.
How similar studies have performed: Machine-learning prognostic models for CRLM have shown promising accuracy in prior publications, but few prior studies have used a multi-reader, multi-case design to test whether such tools actually improve clinician predictions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- No. 17, South Panjiayuan, Chaoyang District, Beijing, Cancer Hospital, Chinese Academy of Medical Sciences, China — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Hong Zhao, MD — Cancer Hospital Chinese Academy of Medical Science
- Study coordinator: Hong Zhao, Md
- Email: zhaohong@cicams.ac.cn
- Phone: +8613381106850
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.