NCT07392567 Prospective Validation of an AI Model for Predicting Liver Metastasis in Colorectal Cancer
| NCT ID | NCT07392567 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tongji Hospital |
| Condition | Colorectal Cancer Liver Metastasis |
| Study Type | OBSERVATIONAL |
| Enrollment | 160 participants |
| Start Date | 2026-01-30 |
| Primary Completion | 2028-01-30 |
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 160 participants in total. It began in 2026-01-30 with a primary completion date of 2028-01-30.
⚠ 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 is a prospective, multicenter, observational study designed to validate the predictive accuracy of a pre-developed multimodal deep learning model. The model integrates preoperative contrast-enhanced CT scans, digitized postoperative pathology images, and standard clinical data to estimate the risk of liver metastasis within two years after curative surgery in patients with stage I-III colorectal cancer. The primary objective is to evaluate the model's performance in an independent, prospectively enrolled patient cohort. Participants will receive standard-of-care treatment according to clinical guidelines. The study involves no experimental interventions; it solely involves the collection and analysis of routinely generated clinical data. The goal is to assess the model's potential for clinical translation by providing a reliable tool for stratifying patients' risk of liver metastasis, which could inform personalized surveillance strategies.
Eligibility Criteria
Inclusion Criteria: * Age 18-75 years, any gender. * Clinical diagnosis of primary colon or rectal adenocarcinoma (Stage I-III). Scheduled to undergo curative radical resection for colorectal cancer. * Preoperative contrast-enhanced abdominal/pelvic CT scan performed within 1 month before surgery, with acceptable image quality. * No evidence of distant metastasis (including synchronous liver metastasis) on preoperative examination. * ECOG Performance Status of 0 or 1. * Patient or their legal representative voluntarily participates and provides written informed consent. Exclusion Criteria: * Postoperative pathological confirmation of non-primary colorectal adenocarcinoma or presence of distant metastasis. * Intraoperative determination of non-R0 resection, or performance of palliative surgery/ostomy only. * History of other malignant tumors. * Previous history of liver surgery or liver transplantation. * Death within the perioperative period (within 30 days after surgery). * Refusal to participate in follow-up, withdrawal of informed consent, or loss to follow-up.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07392567 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Colorectal Cancer Liver Metastasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07392567 currently recruiting?
Yes, NCT07392567 is actively recruiting participants. Contact the research team at 255001907@qq.com for enrollment information.
Where is the NCT07392567 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07392567 clinical trial?
NCT07392567 is sponsored by Tongji Hospital. The trial plans to enroll 160 participants.
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