Development and Application of an HCC Risk Prediction Model Based on Multimodal Data in Chronic Hepatitis B
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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. Approximately 2,000 participants (200 HCC and 1,800 non-HCC) will be included. Model performance will be assessed by AUROC, sensitivity, and specificity through training and validation procedures, with the goal of developing a scalable HCC risk prediction method and software tool for clinical application.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Availability of baseline data and at least two longitudinal follow-up visits.
- •Clinical outcomes during the follow-up period are traceable.
排除标准
- •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).
研究组 & 干预措施
HCC group
Participants who developed HCC within 5 years after enrollment
干预措施: No intervention (observational study) (Other)
Non-HCC group
Participants who did not develop HCC within 5 years after enrollment
干预措施: No intervention (observational study) (Other)
结局指标
主要结局
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
时间窗: Aug, 2026 - Aug, 2027
Evaluation metrics include AUROC, sensitivity, specificity, positive predictive value, negative predictive value, and calibration.
次要结局
- 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(Aug, 2026 - Aug, 2028)