Type 2 Diabetes (T2DM)GAAD-DMNCT07675187
HCC Risk and Monitoring in Patients With Type 2 Diabetes
A study testing GAAD score in people with Type 2 Diabetes (T2DM) and Hepatocellular Carcinoma (HCC), run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes (T2DM), Hepatocellular Carcinoma (HCC)
- What is being tested?
- GAAD score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
National Taiwan University Hospital
Taipei
Tung-Hung Su, +886972651694, tunghungsu@gmail.com
About this study
Official title: Hepatocellular Carcinoma Risk Assessment and Surveillance in Patients With Type 2 Diabetes
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.
- Being tested
- GAAD score
- Keywords
- Type 2 Diabetes, Liver Cancer, Surveillance, Prospective Randomized Study
- Medical subject headings
- Diabetes Mellitus, Type 2, Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAAD scoreDiagnostic test
GAAD score (Gender, age, AFP, DC) will be measured every 6 months in the GAAD Surveillance Group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: GAAD score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tumor diameter of hepatocellular carcinoma (cm).
The maximal tumor diameter of all HCC tumors, measured in centimeters
Measured: From the date of enrollment up to 3 years.
Secondary outcomes (8)
Stage of hepatocellular carcinoma.
The stage of HCC, using the BCLC staging and the AJCC TNM staging
Measured: From the date of enrollment up to 3 years.
Number of hepatocellular carcinoma tumors
The number of HCC tumors evaluated by abdominal CT or MRI exams
Measured: From the date of enrollment up to 3 years
Incidence of hepatocellular carcinoma
The rate of new HCC developed during the study
Measured: From the date of enrollment up to 3 years
Proportion of hepatocellular carcinoma cases receiving curative treatment.
Proportion of hepatocellular carcinoma cases receiving curative treatment (including liver transplantation, surgical resection, local ablation, proton therapy, and etc.)
Measured: From the date of enrollment up to 3 years.
Changes in the degree of liver fibrosis as assessed by the FIB-4 index.
The serial FIB-4 level changes during the study period (measured every 6 months)
Measured: From the date of enrollment up to 3 years.
Participant return-visit rate (adherence to trial follow-up).
The rate of patients who adhere to trial follow-up. Calculated by number of visits divided by total number of planned visits.
Measured: From the date of enrollment up to 3 years.
Incidence of liver cirrhosis.
The number of participants who developed liver cirrhosis (diagnosed by FibroScan > 15 kPa, or a clinical diagnosis by ultrasound, CR, or MRI).
Measured: 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.
The total number of computed tomography (CT) or magnetic resonance imaging (MRI) examinations performed for the purpose of hepatocellular carcinoma screening during the study period.
Measured: From the date of enrollment up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes (T2DM)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tung-Hung Su, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675187
- Sponsor's protocol ID
- 202508145RINC
- Other IDs
- 115-CTC0030
- Acronym
- GAAD-DM
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatocellular Carcinoma Risk Assessment and Surveillance in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07675187
- Acronym / sponsor ID
- GAAD-DM / 202508145RINC
- Keywords
- Type 2 Diabetes, Liver Cancer, Surveillance, Prospective Randomized Study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Diagnostic Test: GAAD scorePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GAAD scoreGAAD score (Gender, age, AFP, DC) will be measured every 6 months in the GAAD Surveillance Group. | Diagnostic test | GAAD Surveillance Group |
Primary outcome
Maximum tumor diameter of hepatocellular carcinoma (cm).
Time frame: From the date of enrollment up to 3 years.
The maximal tumor diameter of all HCC tumors, measured in centimeters
8 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes (T2DM)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SAL0150 Tablets in Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes
RecruitingPhase 3
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
Obesity, Overweight
RecruitingObservational study
Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
T2DM (Type 2 Diabetes Mellitus)
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tung-Hung Su, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GAAD score in people with Type 2 Diabetes (T2DM) and Hepatocellular Carcinoma (HCC), run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tung-Hung Su, PhD (+886-2-23123456, tunghungsu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tumor diameter of hepatocellular carcinoma (cm). (time frame: From the date of enrollment up to 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.