NCT07392567Recruiting
Prospective Validation of an AI Model for Predicting Liver Metastasis in Colorectal Cancer
A Multicenter, Prospective, Observational Study for the Validation of a Multimodal Deep Learning Model to Predict Metachronous Liver Metastasis in Patients With Colorectal Cancer After Curative Resection
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 160 (estimated)
- First submitted
- 30 Jan 2026
- Start date
- 30 Jan 2026
- Primary completion date
- 30 Jan 2028
- Lead sponsor
- Tongji Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07392567
What you commit to
- Study type: Observational
- Planned participants: 160
- From 30 Jan 2026 to the primary completion date, 30 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intraoperative determination of non-R0 resection, or performance of palliative surgery/ostomy only.
- Previous history of liver surgery or liver transplantation.
- Death within the perioperative period (within 30 days after surgery).
Other illness
- History of other malignant tumors.
Other
- Postoperative pathological confirmation of non-primary colorectal adenocarcinoma or presence of distant metastasis.
- Refusal to participate in follow-up, withdrawal of informed consent, or loss to follow-up.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tongji Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.