HCC Risk and Monitoring in Patients With Type 2 Diabetes

NCT07675187 · tracked via the Priya Life Science Taiwan tracker

Sponsor

National Taiwan University Hospital

Phase

Not applicable

Started

2026-07-01

Last updated

2026-07-07

Condition(s) studied

Type 2 Diabetes (T2DM)Hepatocellular Carcinoma (HCC)

Investigational drug(s) / intervention(s)

GAAD score

GAAD score: GAAD score (Gender, age, AFP, DC) will be measured every 6 months in the GAAD Surveillance Group.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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).

Primary outcome measure(s)

Maximum tumor diameter of hepatocellular carcinoma (cm). — From the date of enrollment up to 3 years.
The maximal tumor diameter of all HCC tumors, measured in centimeters

Trial sites (1)

Facility	City	Region	Status
National Taiwan University Hospital	Taipei	Taiwan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07675187 on ClinicalTrials.gov ↗ ← All trials in Taiwan