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
Scientific title
Summary
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