AI model to predict risk of liver spread after colorectal cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, observational study at Tongji Hospital enrolls patients with stage I–III colorectal adenocarcinoma undergoing curative resection to validate a pre-developed multimodal deep learning model. The model combines preoperative contrast-enhanced abdominal/pelvic CT scans, digitized postoperative pathology slides, and routine clinical data to predict the risk of liver metastasis within two years after surgery. Participants receive standard-of-care treatment and no experimental interventions; routinely generated images and clinical records are used to generate model predictions which are later compared to actual outcomes. The primary goal is independent prospective validation of predictive accuracy and generalizability to inform whether the model could be integrated into clinical follow-up planning.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tongji Hospital
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Yang WU, M.D.
• Email: 255001907@qq.com
• Phone: 13636076910

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Multimodal Thermal Therapy for Malignant Liver Tumors

  This study tests a combined cryo- and heat-based therapy to see if it can help people with liver cancers live longer and have fewer tumors.

  Recruiting Fudan University · Shanghai, Shanghai Municipality · NCT07159048

• Fecal transplant plus QL1706, bevacizumab, and XELOX as first-line treatment for advanced MSS colon cancer with liver metastases

  This trial will test whether giving a fecal microbiota transplant before combined QL1706, bevacizumab, and XELOX chemotherapy helps adults with untreated advanced MSS colon cancer that has spread to the liver.

  Recruiting Phase 2 Changzhou No.2 People's Hospital · Changzhou · NCT06801665

• PULSAR combined with PD-1 antibody, chemotherapy, and bevacizumab for colorectal cancer that has spread to the liver

  This trial tests if adding PULSAR radiotherapy to a regimen with a PD-1 blocker, standard chemotherapy, and bevacizumab helps people with colorectal cancer liver metastases live longer without their disease getting worse.

  Recruiting Phase 2 Fujian Cancer Hospital · Fuzhou, Fujian · NCT06788171

• Treatment for colorectal cancer liver metastasis using combined therapies

  This study is testing a new treatment combining a special procedure and medication for people with colorectal cancer that has spread to the liver and hasn't responded to earlier treatments.

  Recruiting Phase 2 Shanghai 6th People's Hospital · Shanghai · NCT06590259

• Botensilimab and balstilimab plus SBRT for liver‑metastatic colorectal cancer

  This tests whether adding two immune drugs, botensilimab and balstilimab, to focused liver radiation (SBRT) can help people with chemorefractory, non‑MSI‑high colorectal cancer that has spread to the liver.

  Recruiting Early Phase 1 Massachusetts General Hospital · Boston, Massachusetts · NCT07128355

• Detecting tumor DNA in small automated capillary blood samples from adults with colorectal cancer liver metastases.

  This project will try whether tiny automated capillary (finger‑prick) blood samples can detect circulating tumor DNA in adults with colorectal cancer that has spread to the liver.

  Recruiting Erasmus Medical Center · Rotterdam, South Holland · NCT07310537

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.