Characterization of Methylation Patterns in Hepatocellular Carcinoma

Sponsor

Nucleix Ltd. (Industry)

Overall Status

Terminated

CT.gov ID

NCT04264754

Collaborator

(none)

120

Enrollment

Locations

35.6

Actual Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma Hepatocellular Cancer Cirrhosis	Procedure: Blood collection

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.

Study Design

Study Type:

Observational

Actual Enrollment :

120 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Characterization of Methylation Patterns in Hepatocellular Carcinoma

Actual Study Start Date :

Feb 13, 2018

Actual Primary Completion Date :

Feb 1, 2021

Actual Study Completion Date :

Feb 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Cases Group 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)	Procedure: Blood collection Peripheral blood will be collected via routine venipuncture procedure
Control Group Cancer free subjects with high risk to development HCC. High risk subjects include the following: Subjects with HCV (hepatitis C virus) and cirrhosis Subjects with HBV (hepatitis B virus) and cirrhosis 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 Subjects with NAFLD (Non-Alcoholic Fatty Liver Disease) with cirrhosis Cirrhotic patients due to any other reasons, including alcohol disease	Procedure: Blood collection Peripheral blood will be collected via routine venipuncture procedure

Arm

Intervention/Treatment

Cases Group

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)

Procedure: Blood collection

Peripheral blood will be collected via routine venipuncture procedure

Control Group

Cancer free subjects with high risk to development HCC. High risk subjects include the following: Subjects with HCV (hepatitis C virus) and cirrhosis Subjects with HBV (hepatitis B virus) and cirrhosis 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 Subjects with NAFLD (Non-Alcoholic Fatty Liver Disease) with cirrhosis Cirrhotic patients due to any other reasons, including alcohol disease

Procedure: Blood collection

Peripheral blood will be collected via routine venipuncture procedure

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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

Contacts and Locations

Locations

	Site	City	Country
1	Ha'emek Medical Center	Afula	Israel
2	Carmel Medical Center	Haifa	Israel
3	Rambam Medical Center	Haifa	Israel
4	Sheba Medical Center	Ramat Gan	Israel
5	Tel Aviv Sourasky Medical Center	Tel Aviv	Israel