Characterization of Methylation Patterns in Hepatocellular Carcinoma

STATUS

Recruiting
End date

Dec 28, 2025
participants needed

1000
sponsor

Nucleix Ltd.

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Updated on 19 February 2024

See if I qualify

cancer

carcinoma

cirrhosis

liver disease

ascites

fatty liver

hepatocellular carcinoma

nash

non-alcoholic fatty liver

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.

Details

Condition	Fibrosis, Adenocarcinoma, Adenocarcinoma, Cirrhosis, LIVER DISEASE, LIVER DISEASE, HEPATIC NEOPLASM, Neoplasm of unspecified nature of digestive system, HEPATOCELLULAR CARCINOMA
Age	22years - 100years
Treatment	Blood collection
Clinical Study Identifier	NCT04264754
Sponsor	Nucleix Ltd.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
	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

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Study Definition

Wikipedia

Characterization of Methylation Patterns in Hepatocellular Carcinoma