NCT07444905Active, not recruiting
Prospective Evaluation of a Locked Risk-Stratified Surveillance Strategy for Extrahepatic Metastasis in Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
This is a multicenter prospective observational cohort study in adults with hepatocellular carcinoma (HCC) without baseline extrahepatic metastasis who are receiving routine clinical management and follow-up at participating centers. The study evaluates the real-world implementation and clinical utility of a locked machine learning-guided risk stratification strategy for predicting lung and bone metastasis and supporting risk-stratified surveillance. The locked strategy uses prespecified 12-month risk thresholds and linked care pathways and is implemented without retraining or threshold revision. No study-mandated treatment or surveillance assignment is performed; clinical care remains at physician discretion according to local practice. The study assesses model transportability and calibration, implementation outcomes (including completion of prespecified actions, timeliness of action, and treatment activation), clinically actionable detection outcomes, patient-important outcomes, and longer-term survival. Comparative analyses use centre- and calendar-epoch-aligned usual-care episodes as the primary observational comparator.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1523 (actual)
- First submitted
- 24 Feb 2026
- Start date
- 1 Feb 2022
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Tongji Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07444905
What you commit to
- Study type: Observational
- Participants enrolled: 1523
- From 1 Feb 2022 to the primary completion date, 30 Dec 2026
- 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.
Other illness
- History of other active malignancy within the past 5 years, except adequately treated non-melanoma skin cancer or in situ carcinoma.
Other
- Confirmed extrahepatic metastasis at enrollment (baseline).
- Incomplete baseline clinical information that precludes model-based risk assessment.
- Expected survival \< 3 months due to severe comorbidities.
- Participation in an interventional clinical trial that may substantially alter follow-up strategy or metastasis assessment.
Who the study is looking for
- Age ≥ 18 years.
- Diagnosis of hepatocellular carcinoma (HCC) confirmed by histopathology or accepted radiologic criteria per international guidelines.
- No evidence of extrahepatic metastasis at baseline evaluation.
- Receiving standard-of-care management with planned longitudinal follow-up in routine clinical practice.
- Availability of baseline clinical and imaging data required for risk assessment using the pre-specified machine learning model.
- Ability to provide written informed consent, or inclusion under ethics committee-approved procedures.
Age in the registry: 18 years to - · 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, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.