Cirrhosis, Hepatocellular Cancer, Hepatocellular Carcinoma
Conditions
Keywords
Cirrhosis, Hepatocellular Carcinoma, Methylation, HCC
Brief summary
This study is being performed as part of the development process of the Liver EpiCheck test which includes the identification of different methylation profiles in HCC (hepatocellular carcinoma) patients compare to cancer free control in blood samples
Detailed description
This is a prospective, multi-center, observational study aimed to collect blood samples and de-identified clinical data from subjects diagnosed with HCC (cases arm) and subjects with high risk for HCC which are undergoing routine surveillance for HCC.
Interventions
PROCEDUREBlood collection
Peripheral blood will be collected via routine venipuncture procedure
Sponsors
Nucleix Ltd.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Case Group: * Age ≥ 22 years * Subjects who are willing and able to provide written informed consent * Subjects with confirmed diagnosis of HCC, naïve to tumor directed therapy
Exclusion criteria
- Case Group: * Subjects with current cancer of any kind, other than hepatocellular carcinoma * Subjects with a history of cancer of any kind (including hepatocellular carcinoma), other than non-melanoma skin cancer completely resected * Coinfection with HIV * Prior solid organ transplant Inclusion Criteria - Control Group: * Age ≥ 22 years * Subjects who are willing and able to provide written informed consent * Subjects diagnosed with one of the following: i. Subjects with HCV and cirrhosis ii. Subjects with HBV and cirrhosis iii. Non-cirrhotic chronic HBV subjects at intermediate or high risk of HCC, according to EASL Clinical Practice Guidelines for the management of hepatocellular carcinoma iv. Subjects with Non-Alcoholic Fatty Liver Disease (NAFLD) with cirrhosis. v. Cirrhotic patients due to any other reasons, including alcohol disease * Subjects currently undergoing surveillance for hepatocellular carcinoma * HCC surveillance imaging (e.g., US, CT, MRI) performed within 3 months prior to baseline visit * Subjects with compensated liver function as measured by Child-Pugh Score A or B7 without ascites (all measures should be from the last three months)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To collect blood samples and clinical data in order to characterize methylation patterns that will discriminate between HCC and normal hepatic tissue | 60 months | To collect blood samples and clinical data in order to characterize methylation patterns that will discriminate between HCC and normal hepatic tissue |
| To develop a molecular blood test that will be able to detect HCC based on change in methylation patterns between HCC and normal hepatic tissue | 60 months | To develop a molecular blood test that will be able to detect HCC based on change in methylation patterns between HCC and normal hepatic tissue |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liver EpiCheck Performance | 60 months | To assess the performance of the Liver EpiCheck in terms of (1) Sensitivity (2) Specificity (3) NPV(negative predictive value) and (4) PPV (positive predictive value) |
Countries
Israel
Outcome results
None listed