Liver DiseasesNCT04965259
Early Detection of Hepatocellular Carcinoma in a High-risk Prospective Cohort (ELEGANCE)
An observational study of Liver Diseases, run by National Cancer Centre, Singapore at 14 sites in Singapore.
Trial summary
Hepatocellular carcinoma (HCC) is the 7th most common cause of cancer death globally but only 20% are diagnosed in its early stages where cure is possible. Current standard-of-care surveillance of patients at high risk of developing HCC with 6-monthly serum alpha-fetoprotein (AFP) and ultrasound imaging (US) has a… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Liver Diseases
- How many people
- 2,002 participants
- Where
- 14 sitesSingapore
- Study dates
- 15 Apr 2021to 21 Dec 2026
- Phase
- Observational
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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:
- liver cirrhosis of any etiology, identified by elastography (liver stiffness > 13 kPa), US, CT, MRI or liver biopsy, Child-Pugh class A and B
Show all 11Show fewer
- non-cirrhotic chronic viral hepatitis (B or C) or both
- non-alcoholic fatty liver disease (NAFLD)
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Singapore14 sites
National University Hospital
Singapore, 119228
SingHealth Polyclinics - Bukit Merah
Singapore, 150163
National Cancer Center Singapore
Singapore, 168583
SingHealth Polyclinics - Outram
Singapore, 168937
Singapore General Hospital
Singapore, 169608
Tan Tock Seng Hospital
Singapore, 308433
SingHealth Polyclinics - Marine Parade
Singapore, 440080
SingHealth Polyclinics - Bedok
Singapore, 469662
SingHealth Polyclinics - Pasir Ris
Singapore, 519457
SingHealth Polyclinics - Tampines
Singapore, 529203
Changi General Hospital
Singapore, 529889
Sengkang General Hospital
Singapore, 544886
SingHealth Polyclinics - Sengkang
Singapore, 545025
SingHealth Polyclinics - Punggol
Singapore, 820681
About this study
Official title: Early Detection of Hepatocellular Carcinoma (HCC): miRNA, Microbiome and Imaging Biomarkers in the Evolution of Chronic Liver Disease in a High-risk Prospective Cohort (ELEGANCE)
Hepatocellular carcinoma (HCC) is the 7th most common cause of cancer death globally but only 20% are diagnosed in its early stages where cure is possible. Current standard-of-care surveillance of patients at high risk of developing HCC with 6-monthly serum alpha-fetoprotein (AFP) and ultrasound imaging (US) has a sensitivity of approximately 63% for detecting early HCC. There is an urgent need for a more efficacious and convenient modality of surveillance of high-risk patients to diagnose HCC at an early stage.
This prospective study aims to address this unmet clinical need by validating a panel of circulating miRNA biomarkers to develop an in-vitro diagnostic (IVD) kit for the detection of early HCC in a cohort of high-risk patients.
Additionally, this study also aims to develop a multi-parametric MRI-based AI algorithm to quantify individual risks of developing HCC and to predict the progression of chronic liver disease in this cohort to enable targeted surveillance. Lastly, by identifying changes in the microbiome and metabolites as HCC develops in this cohort enables the establishment of actionable biomarkers that can prevent and predict the development of HCC.
Read the detailed description
Eligible patients will receive 6-monthly standard-of-care surveillance (US, serum AFP and liver function test) for HCC until end of study or up to a maximum of 7 assessments (1 baseline and 6 follow-up assessments). There will be an option for patients to continue to receive standard-of-care surveillance for HCC until end of study or up to 6 additional assessments (Visits 8-13), whichever occurs first.
Patients with elevated AFP or abnormalities detected on US will be investigated with multi-phasic CT scan or MRI to confirm or refute the diagnosis of HCC. Additionally, patients shall be scheduled for sequential bio-samples collection (blood, urine and stool) and blood tests (Hba1c and Lipid Panel) during the course of the study.
- Conditions
- Liver Diseases
- Keywords
- Hepatocellular Carcinoma(HCC), Surveillance, Patients-at-risk, miRNA, Precision medicine, Gut microbiota, Metabolites, Microbiome biomarkers, Circulating biomarkers, MRI
- Medical subject headings
- Liver Diseases, Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the profile of circulating micro-RNA biomarkers as high-risk patients develop HCC
Changes in the profile of circulating micro-RNA biomarkers as high-risk patients develop HCC
Measured: Baseline and every 6 months thereafter, and at HCC diagnosis every 6 months thereafter up to 70 months.
value of cT1, PDFF and T2* levels to predict individual's risk of developing and progression of HCC.
value of cT1, PDFF and T2* levels to predict individual's risk of developing and progression of HCC.
Measured: Baseline and upon elevated AFP or US which is suggestive of HCC, up to 70 months.
Changes in the profile of gut microbiota as high-risk patients develop HCC.
Changes in the profile of gut microbiota as high-risk patients develop HCC.
Measured: Baseline and every 6 months thereafter, up to 70 months
Changes in the profile of metabolome in urine and plasma as high-risk patients develop HCC.
Changes in the profile of metabolome in urine and plasma as high-risk patients develop HCC.
Measured: Baseline and every 6 months thereafter, up to 70 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start15 Apr 2021
- Primary completion11 Mar 2025
- Study completion21 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School, Singapore Phenome Centre, Nanyang Technological University, MiRXES Pte Ltd, Perspectum Asia Pte Ltd, Asian Microbiome Library Pte Ltd
- Responsible party
- Sponsor
- Investigators
- Pierce Chow, MD, PhD, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965259
- Sponsor's protocol ID
- AHCC10 ELEGANCE
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2021
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Hepatocellular Carcinoma (HCC): miRNA, Microbiome and Imaging Biomarkers in the Evolution of Chronic Liver Disease in a High-risk Prospective Cohort (ELEGANCE)
- ClinicalTrials.gov ID
- NCT04965259
- Acronym / sponsor ID
- AHCC10 ELEGANCE
- Conditions
- Liver Diseases
- Keywords
- Hepatocellular Carcinoma(HCC), Surveillance, Patients-at-risk, miRNA, Precision medicine, Gut microbiota, Metabolites, Microbiome biomarkers
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,002 participants (actual)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School, Singapore Phenome Centre, Nanyang Technological University, MiRXES Pte Ltd, Perspectum Asia Pte Ltd, Asian Microbiome Library Pte Ltd
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 21 Dec 2026 (estimated)
- First posted
- 16 Jul 2021 (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.
Hepatocellular carcinoma (HCC) is the 7th most common cause of cancer death globally but only 20% are diagnosed in its early stages where cure is possible. Current standard-of-care surveillance of patients at high risk of developing HCC with 6-monthly serum alpha-fetoprotein (AFP) and ultrasound imaging (US) has a sensitivity of approximately 63% for detecting early HCC. There is an urgent need for a more efficacious and convenient modality of surveillance of high-risk patients to diagnose HCC at an early stage.
This prospective study aims to address this unmet clinical need by validating a panel of circulating miRNA biomarkers to develop an in-vitro diagnostic (IVD) kit for the detection of early HCC in a cohort of high-risk patients.
Additionally, this study also aims to develop a multi-parametric MRI-based AI algorithm to quantify individual risks of developing HCC and to predict the progression of chronic liver disease in this cohort to enable targeted surveillance. Lastly, by identifying changes in the microbiome and metabolites as HCC develops in this cohort enables the establishment of actionable biomarkers that can prevent and predict the development of HCC.
Detailed description
Eligible patients will receive 6-monthly standard-of-care surveillance (US, serum AFP and liver function test) for HCC until end of study or up to a maximum of 7 assessments (1 baseline and 6 follow-up assessments). There will be an option for patients to continue to receive standard-of-care surveillance for HCC until end of study or up to 6 additional assessments (Visits 8-13), whichever occurs first.
Patients with elevated AFP or abnormalities detected on US will be investigated with multi-phasic CT scan or MRI to confirm or refute the diagnosis of HCC. Additionally, patients shall be scheduled for sequential bio-samples collection (blood, urine and stool) and blood tests (Hba1c and Lipid Panel) during the course of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in the profile of circulating micro-RNA biomarkers as high-risk patients develop HCC
Time frame: Baseline and every 6 months thereafter, and at HCC diagnosis every 6 months thereafter up to 70 months.
Changes in the profile of circulating micro-RNA biomarkers as high-risk patients develop HCC
value of cT1, PDFF and T2* levels to predict individual's risk of developing and progression of HCC.
Time frame: Baseline and upon elevated AFP or US which is suggestive of HCC, up to 70 months.
value of cT1, PDFF and T2* levels to predict individual's risk of developing and progression of HCC.
Changes in the profile of gut microbiota as high-risk patients develop HCC.
Time frame: Baseline and every 6 months thereafter, up to 70 months
Changes in the profile of gut microbiota as high-risk patients develop HCC.
Changes in the profile of metabolome in urine and plasma as high-risk patients develop HCC.
Time frame: Baseline and every 6 months thereafter, up to 70 months.
Changes in the profile of metabolome in urine and plasma as high-risk patients develop HCC.
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 17 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Pierce Chow, MD, PhD principal investigator
National Cancer Centre, Singapore
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases, run by National Cancer Centre, Singapore at 14 sites in Singapore.
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 11 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 17 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 14 sites in Singapore. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the profile of circulating micro-RNA biomarkers as high-risk patients develop HCC (time frame: Baseline and every 6 months thereafter, and at HCC diagnosis every 6 months thereafter up to 70 months.). The study lists 4 primary outcomes in all. 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 17 Jul 2026.