Early Detection of Hepatocellular Carcinoma in a High-risk Prospective Cohort (ELEGANCE)

Trial number:
NCT04965259
Trial phase:
N/A
Study type:
Observational
Overall status:
Recruiting

Study start date

April, 2021

Scientific 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)

Summary

Hepatocellular carcinoma (HCC) is the 2nd 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 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.

Male and female patients, 50 to 90 years of ago at the time of signing the informed consent form.Patient has serum alpha-fetoprotein (AFP) within normal range of the investigating laboratory 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 has chronic liver disease other than HCC in the last 5 years 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 (based on the judgement of the Investigator)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

Patient with confirmed diagnosis of HCC by the American Association for the Study of the Liver Disease (AASLDC) imaging criteria or histology / cytology within the last 5 yearsPatient 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 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

Study design

Time perspective: Prospective, Observational model: Cohort,

Conditions

Liver Diseases

Other study ID numbers

AHCC10 ELEGANCE

Choose trial site (15)

National Cancer Centre Singapore
National Cancer Centre Singapore Completed