Characterization of Methylation Patterns in Hepatocellular Carcinoma

Terminated

• Conditions: Cirrhosis; Hepatocellular Carcinoma; Hepatocellular Cancer
• Interventions: Procedure: Blood collection

• Registration Number: NCT04264754
• Lead Sponsor: Nucleix Ltd.

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.

Study Timeline

• Study Start: 2018-02-13
• Study First Submitted: 2020-02-09
• Study First Submitted QC: 2020-02-09
• Study First Posted: 2020-02-11
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases Group	Blood collection	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)
Control Group	Blood collection	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

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (5)

Rambam Medical Center; 🇮🇱 Haifa, Israel

Ha'emek Medical Center; 🇮🇱 Afula, Israel

Carmel Medical Center; 🇮🇱 Haifa, Israel

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel