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Development and Validation of an AI-Based Model for Diagnosis and Prognosis Prediction in Hepatobiliary Malignancies

Development and Validation of an AI-Based Model for Diagnosis and Prognosis Prediction in Hepatobiliary Malignancies

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500107856
Enrollment
Unknown
Registered
2025-08-20
Start date
2025-08-25
Completion date
Unknown
Last updated
2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant tumors of the hepatobiliary system

Interventions

Index test:Imaging: Computed Tomography. Pathology: Histopathology, immunohistochemistry (IHC), and molecular pathology. Blood biochemical parameters: Albumin/Globulin ratio, ALP, Prealbumin, Direct b

Sponsors

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Pathological diagnosis: All subjects must be pathologically confirmed and provide clear histological evidence. Patients with malignant tumors must have complete pathological staging information according to the AJCC 8th edition TNM staging system; 2. Age requirements: Subject age >=18 years old, gender is not limited. Considering that hepatobiliary malignancies are more common in the elderly population, there is no upper age limit to ensure the representativeness of the sample; 3. Complete imaging data: complete preoperative imaging examination data, including multi-stage CT or MRI image data, and the image quality meets the analysis requirements; 4. Complete pathological data: complete postoperative pathological sections and WSI digital pathological data, clear H&E staining, suitable for deep learning analysis; 5. Complete clinical data: complete clinical data such as clinical examination data, surgical records, diagnosis and treatment; 6. Follow-up information is available: The patient's prognosis information can be obtained through the hospital system or follow-up, including survival status, recurrence and metastasis, etc.

Exclusion criteria

Exclusion criteria: 1.Concurrent presence of two or more malignant tumors, or hepatobiliary malignant tumor lesions that are non-primary (metastatic) lesions; 2.Comorbid severe central nervous system diseases, respiratory system diseases, autoimmune diseases, chronic renal insufficiency, or other diseases; long-term use of immunosuppressive agents; comorbid severe uncontrolled infections; 3.Concurrent active cardiovascular and cerebrovascular diseases, including cerebrovascular accident, myocardial infarction, or unstable angina within 6 months; congestive heart failure of Class II or above according to New York Heart Association (NYHA) criteria; severe arrhythmias requiring pharmacological treatment; 4.Women of childbearing age with positive blood pregnancy tests or who have not undergone pregnancy testing; pregnant or lactating women; 5.Patients who participated in other therapeutic clinical trials with unclear treatment measures or from which treatment information cannot be collected during their illness period.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;Accuracy;

Secondary

MeasureTime frame
Prealbumin;Albumin/Globulin Ratio;Carcinoembryonic Antigen;Direct Bilirubin;Carbohydrate Antigen 15-3;Alkaline Phosphatase;Carbohydrate Antigen 19-9;Carbohydrate Antigen 125;Total Bilirubin;Alpha-Fetoprotein;

Countries

China

Contacts

Public ContactLi Maolan

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine

limaolan6@163.com+86 21 58752345

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026