This is a prospective, single-arm, non-randomized interventional study nested within the existing ELEGANCE cohort. Patients eligible for the RE-BALANCE study will be selected from the ELEGANCE cohort based on predefined high-risk criteria, specifically a low 12-non-hydroxy/12-hydroxy bile acid ratio indicative of elevated hepatocarcinogenic risk.
The study comprises Baseline Assessments (Visit 1), Intervention Visits (Visit 2-8), and Follow-up Assessments (Visit 9-11).
The patient is an existing participant of the ELEGANCE study and shows no evidence of hepatocellular carcinoma (HCC) at the time of enrolment into RE-BALANCE.
Male and female patients aged 50 to 90 years at the time of informed consent are eligible. However, patients with cirrhosis may be included if they are aged 40 to 90 years.
Negative for hepatitis B surface antigen (HBsAg) and hepatitis C antibody
High-risk bile acid profile, defined as a 12-non-hydroxy/12-hydroxy bile acid ratio below the threshold determined from ELEGANCE cohort data.
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 or decompensated 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).
National Cancer Centre, Singapore
Lead sponsor
Perspectum
Collaborator
BUZUD Pte Ltd
Collaborator
Asian Microbiome Library (AMiLi) Pte Ltd
Collaborator