Characterization of Methylation Patterns in Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Characterization of Methylation Patterns in Hepatocellular Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04264754
• Other study ID #: Liver-RND-001
• Status: Terminated
• Start date: February 13, 2018
• Est. completion date: February 1, 2021

Study information

• Verified date: May 2021
• Source: Nucleix Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Cirrhosis
• Fibrosis
• Hepatocellular Cancer
• Hepatocellular Carcinoma
• Liver Neoplasms

Intervention

Procedure:
• Blood collection
Peripheral blood will be collected via routine venipuncture procedure

Locations

Country	Name	City	State
Israel	Ha'emek Medical Center	Afula
Israel	Carmel Medical Center	Haifa
Israel	Rambam Medical Center	Haifa
Israel	Sheba Medical Center	Ramat Gan
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Nucleix Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To collect blood samples and clinical data in order to characterize methylation patterns that will discriminate between HCC and normal hepatic tissue	To collect blood samples and clinical data in order to characterize methylation patterns that will discriminate between HCC and normal hepatic tissue	60 months
Primary	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	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
Secondary	Liver EpiCheck Performance	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)	60 months