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Blood test and AI could spot liver cancer early, saving lives

NCT ID NCT04965259

Knowledge-focused Sponsor: National Cancer Centre, Singapore 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study follows 2,002 people at high risk for liver cancer to find better ways to detect it early. Researchers are testing a panel of blood-based miRNA markers, gut microbiome changes, and MRI-based AI algorithms to predict who develops the disease. The goal is to improve on current surveillance methods, which miss about 37% of early-stage cancers.

What this could mean

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

What this could lead to
If successful, this could lead to a simple blood test and AI-based imaging to catch liver cancer early, when it is curable.
What could go wrong
This is an observational study, not a treatment trial. The biomarkers may not prove accurate enough for widespread use, and results may take years.

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.

Participants

2,002 people

The number who actually took part.

Started

Apr 2021

Expected to finish

Dec 2026

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.

Who is studied

Patients at high-risk of developing HCC forming a cohort of patients with cirrhosis from any etiology, chronic hepatitis B without significant cirrhosis, chronic hepatitis C without significant cirrhosis and NAFLD/NASH without significant cirrhosis.

Ages

40 to 90 years

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: * Male and female patients, 50 to 90 years of age at the time of signing the informed consent form, except for patients recruited under the cirrhotic group, patients of 40 to 90 years of age can be included. * Patient has serum alpha-fetoprotein (AFP) within normal range of the investigating laboratory in the past 3 months. For patients with AFP level out of the normal range of the investigating laboratory and up to 15.0ug/L, patient will be eligible if patient has a CT/MRI scan that exclude HCC in the past 3 months. * Patient has ultrasound hepatobiliary system (US HBS) that does not show lesion suspicious for HCC or, CT / MRI scan that exclude HCC, in the past 3 months * Patient is estimated to survive more than 3 years * Patient with any of the following chronic liver disease: 1. liver cirrhosis of any etiology, identified by elastography (liver stiffness \> 13 kPa), US, CT, MRI or liver biopsy, Child-Pugh class A and B 2. non-cirrhotic chronic viral hepatitis (B or C) or both 3. non-alcoholic fatty liver disease (NAFLD) 4. non-alcoholic steatohepatitis (NASH) * Patient is able to comply with scheduled visits, assessments and other study procedures * Patient is willing to provide informed consent before enrolment in the study Exclusion Criteria: * Patient with confirmed diagnosis of HCC by the American Association for the Study of the Liver Disease (AASLD) imaging criteria or histology / cytology within the last 5 years * Patient with Child-Pugh C cirrhosis at time of enrolment (based on the judgement of the Investigator) * Patient with active hepatic encephalopathy at time of enrolment * Patient is known to be positive for the Human Immunodeficiency Virus (HIV) * Patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the study procedures * Patient is unable to provide informed consent or refuse blood taking * Patient has any other condition which, in the opinion of the Investigators, would make the patient unsuitable for enrolment or could interfere with completion of the study

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection chronic hepatitis C virus infection cirrhosis of liver hepatocellular carcinoma liver disorder metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

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

Liver diseases

Contacts and locations

Locations

  • Changi General Hospital

    Singapore, 529889, Singapore

  • National Cancer Center Singapore

    Singapore, 168583, Singapore

  • National University Hospital

    Singapore, 119228, Singapore

  • Sengkang General Hospital

    Singapore, 544886, Singapore

  • SingHealth Polyclinics - Bedok

    Singapore, 469662, Singapore

  • SingHealth Polyclinics - Bukit Merah

    Singapore, 150163, Singapore

  • SingHealth Polyclinics - Marine Parade

    Singapore, 440080, Singapore

  • SingHealth Polyclinics - Outram

    Singapore, 168937, Singapore

  • SingHealth Polyclinics - Pasir Ris

    Singapore, 519457, Singapore

  • SingHealth Polyclinics - Punggol

    Singapore, 820681, Singapore

  • SingHealth Polyclinics - Sengkang

    Singapore, 545025, Singapore

  • SingHealth Polyclinics - Tampines

    Singapore, 529203, Singapore

  • Singapore General Hospital

    Singapore, 169608, Singapore

  • Tan Tock Seng Hospital

    Singapore, 308433, Singapore

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