Characterization of Methylation Patterns in Hepatocellular Carcinoma

Nucleix

Status: Terminated

Conditions: Cirrhosis; Hepatocellular Cancer; Hepatocellular Carcinoma

Treatments: Procedure: Blood collection

Study type: Observational

Funder types: Industry

Identifiers

NCT04264754

Liver-RND-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Exclusion Criteria - Control 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
• Current substance abuse

Trial design

120 participants in 2 patient groups

Cases Group

Description:

Subjects who have already been diagnosed with liver cancer, however did not yet undergo any surgery, ablation, embolization or any other treatment for this cancerous lesion (including, but not limited to systemic therapies)

Treatment:

Procedure: Blood collection

Control Group

Description:

Cancer free subjects with high risk to development HCC. High risk subjects include the following: 1. Subjects with HCV (hepatitis C virus) and cirrhosis 2. Subjects with HBV (hepatitis B virus) and cirrhosis 3. Non-cirrhotic chronic HBV subjects at intermediate or high risk of HCC, according to EASL (European Association for the Study of the Liver) Clinical Practice Guidelines for the management of hepatocellular carcinoma 4. Subjects with NAFLD (Non-Alcoholic Fatty Liver Disease) with cirrhosis 5. Cirrhotic patients due to any other reasons, including alcohol disease

Treatment:

Procedure: Blood collection