Hepatocellular Carcinoma Risk Assessment and Surveillance in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,400
- 试验地点
- 1
- 主要终点
- Incidence of Hepatocellular Carcinoma (HCC)
研究概览
简要总结
Liver cancer is a significant malignancy in Taiwan. With the widespread implementation of antiviral therapies, hepatitis B and C-related liver cancer has gradually declined; however, metabolic dysfunction-associated liver cancer continues to increase, particularly among patients with type 2 diabetes mellitus (T2DM) who also present with significant liver fibrosis. Current clinical guidelines lack standardized recommendations for liver cancer screening in this specific population, and data from prospective randomized controlled trials remain scarce.This study is a prospective randomized controlled trial enrolling patients aged 18 years, diagnosed with T2DM, and with a FIB-4 > 2.67. Participants will be randomly assigned to either the surveillance group or the standard-care group. The surveillance group will undergo blood tests every 6 months to monitor liver function, AFP, and PIVKA-II, alongside the calculation of the GAAD score. The standard-care group will receive liver function tests every 6 months according to routine clinical practice. Abdominal ultrasound or computed tomography (CT) scans will be arranged by clinicians when clinically indicated. All participants will undergo abdominal ultrasound at baseline and at the end of the third year, with blood samples and clinical data collected periodically. The primary endpoint of this study is the tumor size at the time of liver cancer diagnosis. Secondary endpoints include liver cancer staging, number of liver cancer tumors, liver cancer incidence, the proportion of patients receiving curative treatment, and the degree of liver fibrosis as reflected by changes in FIB-4. This study expects to clarify the clinical benefits of a GAAD score-based surveillance strategy compared to standard care in T2DM patients with high FIB-4 scores, thereby providing evidence-based support for future liver cancer screening strategies and clinical guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
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
- •Age 18 years or older.
- •Diagnosed with type 2 diabetes mellitus and clinically followed with regular outpatient visits.
- •FIB-4 index greater than 2.67 (calculated based on AST, ALT, and platelet count within the past 6 months).
- •Willing and able to provide written informed consent.
排除标准
- •HBsAg positive.
- •Anti-HCV positive and HCV RNA positive (patients with anti-HCV positive but negative HCV RNA are still eligible).
- •Prior history of hepatobiliary malignancies.
- •Undergoing regular abdominal ultrasound screening more than once per year.
- •Established diagnosis of liver cirrhosis via abdominal ultrasound or clinical evaluation.
- •Diagnosed with or treated for any malignancy within the past 2 years.
- •Women of childbearing potential or pregnant women.
- •Thrombocytopenia secondary to hematologic disorders.
- •Known history of human immunodeficiency virus (HIV) infection.
- •Concomitant use of medications that may interfere with PIVKA-II assay results (e.g., warfarin, vitamin K).
研究组 & 干预措施
Standard Care Group
Patients with type 2 diabetes and high FIB-4 scores who receive standard clinical care and routine follow-up without the specified GAAD score surveillance protocol.
结局指标
主要结局
Incidence of Hepatocellular Carcinoma (HCC)
时间窗: From the date of enrollment up to 3 years.
The proportion of patients diagnosed with hepatocellular carcinoma (HCC) during the follow-up period. Diagnosis will be confirmed by dynamic imaging (CT/MRI) or histopathological examination according to standard clinical guidelines.
Maximum tumor diameter of hepatocellular carcinoma (cm).
时间窗: From the date of enrollment up to 3 years.
The maximal tumor diameter of all HCC tumors, measured in centimeters
次要结局
- Stage of hepatocellular carcinoma.(From the date of enrollment up to 3 years.)
- Number of hepatocellular carcinoma tumors(From the date of enrollment up to 3 years)
- Incidence of hepatocellular carcinoma(From the date of enrollment up to 3 years)
- Proportion of hepatocellular carcinoma cases receiving curative treatment.(From the date of enrollment up to 3 years.)
- Changes in the degree of liver fibrosis as assessed by the FIB-4 index.(From the date of enrollment up to 3 years.)
- Participant return-visit rate (adherence to trial follow-up).(From the date of enrollment up to 3 years.)
- Incidence of liver cirrhosis.(From the date of enrollment up to 3 years.)
- Number of computed tomography (CT) or magnetic resonance imaging (MRI) examinations performed for the purpose of hepatocellular carcinoma screening.(From the date of enrollment up to 3 years.)
研究者
National Taiwan University Clinical Trial Center
Attending Physician
National Taiwan University Hospital