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Simple blood tests could spot liver cancer earlier in diabetics

NCT ID NCT07675187

Disease control Sponsor: National Taiwan University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This study investigates whether regular blood tests can detect liver cancer earlier in people with type 2 diabetes who also have significant liver scarring. Participants are randomly assigned to either a surveillance group receiving specialized blood tests every six months or a standard-care group. The goal is to see if the surveillance strategy leads to smaller tumors at diagnosis and better treatment outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GAAD score-based surveillance (blood tests for AFP, PIVKA-II, and liver function)
What this could lead to
If successful, this could establish a simple blood-test strategy to catch liver cancer earlier in people with type 2 diabetes, potentially improving treatment options and survival.
What could go wrong
This is a single-center trial in Taiwan, so results may not apply globally. The surveillance approach may not significantly improve detection or outcomes compared to standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,400 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

Liver Neoplasms type 2 diabetes mellitus hepatocellular carcinoma prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatocellular carcinoma (HCC) Type 2 diabetes (T2DM)

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Taiwan University Hospital

    Taipei, Taiwan

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