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 IdentifierNCT04264754
SponsorNucleix Ltd.
Last Modified on19 February 2024

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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