HCC Risk and Monitoring in Patients With Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GAAD score.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes (T2DM), Hepatocellular Carcinoma (HCC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Hepatocellular Carcinoma Risk Assessment and Surveillance in Patients With Type 2 Diabetes
Overview
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.
Interventions
- Diagnostic test GAAD score
GAAD score (Gender, age, AFP, DC) will be measured every 6 months in the GAAD Surveillance Group.
Primary outcome measures
- Maximum tumor diameter of hepatocellular carcinoma (cm). [Time frame: From the date of enrollment up to 3 years.]
Secondary outcome measures (8)
- Stage of hepatocellular carcinoma. [Time frame: From the date of enrollment up to 3 years.]
- Number of hepatocellular carcinoma tumors [Time frame: From the date of enrollment up to 3 years]
- Incidence of hepatocellular carcinoma [Time frame: From the date of enrollment up to 3 years]
- Proportion of hepatocellular carcinoma cases receiving curative treatment. [Time frame: From the date of enrollment up to 3 years.]
- Changes in the degree of liver fibrosis as assessed by the FIB-4 index. [Time frame: From the date of enrollment up to 3 years.]
- Participant return-visit rate (adherence to trial follow-up). [Time frame: From the date of enrollment up to 3 years.]
- Incidence of liver cirrhosis. [Time frame: 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. [Time frame: From the date of enrollment up to 3 years.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Screening
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT07675187 · 202508145RINC · 115-CTC0030