HCC Risk and Monitoring in Patients With Type 2 Diabetes

NCT07675187 | Not Yet Recruiting

• 2 other identifiers: 202508145RINC115-CTC0030
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma (HCC); Type 2 Diabetes (T2DM)

Keywords

Type 2 Diabetes; Liver Cancer; Surveillance; Prospective Randomized Study

Outcome Measures

Primary Outcomes (1)

• Maximum tumor diameter of hepatocellular carcinoma (cm).

  The maximal tumor diameter of all HCC tumors, measured in centimeters

  From the date of enrollment up to 3 years.

Secondary Outcomes (8)

• 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.

Study Arms (2)

Standard Care Group

NO INTERVENTION

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.

GAAD Surveillance Group

EXPERIMENTAL

Patients with type 2 diabetes and high FIB-4 scores who undergo regular HCC surveillance using the GAAD score (gender, age, AFP, and AFP-L3) algorithm.

Diagnostic Test: GAAD score

Interventions

GAAD score DIAGNOSTIC_TEST

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

GAAD Surveillance Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Tung-Hung Su, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tung-Hung Su, PhD

CONTACT

+886-2-23123456; tunghungsu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)