About this trial
The investigators propose to construct and validate an early HCC risk prediction model in a multicenter retrospective cohort of hepatitis B-related fibrosis/cirrhosis patients, using multimodal data encompassing longitudinal clinical data, serum glycomics profiles, and liver biopsy histopathological images.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18 years, both sexes eligible.
Diagnosed with hepatitis B-related liver fibrosis or cirrhosis based on clinical assessment or liver histopathology.
Undergoing antiviral treatment.
Follow-up duration between 0.5- 5 years.
Disqualifiers
Diagnosis of Hepatocellular carcinoma (HCC) or liver transplantation at baseline or within 6 months after baseline/enrollment.
Coexisting other chronic liver diseases, such as genetic/metabolic liver diseases, drug-induced liver injury, or severe steatotic liver disease.
Coexisting other malignancies (except those considered cured).
Trial population
Patients with HBV-related fibrosis/cirrhosis on antiviral therapy from a multicenter retrospective cohort, with available longitudinal clinical data, serum glycomics, and liver histopathology.
Trial design
Cohort
Retrospective
Treatments tested in this trial
No intervention (observational study)
Other interventionNo intervention (observational study)
Treatment groups
Trial outcomes
Primary outcomes
To evaluate the predictive performance of an early-stage HCC risk prediction model integrating longitudinal clinical data and serum glycomics biomarkers in patients with hepatitis B-related fibrosis
Evaluation metrics include AUROC, sensitivity, specificity, positive predictive value, negative predictive value, and calibration.
Secondary outcomes
To evaluate the predictive performance of an early HCC risk prediction model integrating liver histopathological imaging with longitudinal clinical and serum glycomics data in patients with hepatitis B-related fibrosis
Evaluation metrics include AUROC, sensitivity, specificity, positive predictive value, negative predictive value, and calibration.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Friendship Hospital
Lead sponsor
The Second Hospital & Clinical Medical School, Lanzhou University
Collaborator
Beijing Ditan Hospital
Collaborator
Yuncheng Central Hospital
Collaborator
Guangzhou Eighth People's Hospital, Guangzhou Medical University.
Collaborator
This trial is not recruiting at the moment. You can still explore other options: