NCT07675187Not yet recruiting
HCC Risk and Monitoring in Patients With Type 2 Diabetes
Hepatocellular Carcinoma Risk Assessment and Surveillance in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 2400 (estimated)
- First submitted
- 23 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- National Taiwan University Hospital
- NCT number
- NCT07675187
What you commit to
- Study type: Interventional
- Planned participants: 2400
- From 1 Jul 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of hepatobiliary malignancies.
- Concomitant use of medications that may interfere with PIVKA-II assay results (e.g., warfarin, vitamin K).
Other illness
- Anti-HCV positive and HCV RNA positive (patients with anti-HCV positive but negative HCV RNA are still eligible).
- Diagnosed with or treated for any malignancy within the past 2 years.
- Thrombocytopenia secondary to hematologic disorders.
- Known history of human immunodeficiency virus (HIV) infection.
Other
- HBsAg positive.
- Undergoing regular abdominal ultrasound screening more than once per year.
- Established diagnosis of liver cirrhosis via abdominal ultrasound or clinical evaluation.
- Women of childbearing potential or pregnant women.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.