An observational study in Hepatocellular Carcinoma, Hepatocellular Cancer and Cirrhosis, sponsored by Nucleix Ltd.. Terminated at 5 sites in Israel. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2021-05-06.
Sponsored by Nucleix Ltd. · Observational
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
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.
6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.
This study's enrollment of 120 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Nucleix Ltd. is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
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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) will be enlisted into the study as the Case group.
In addition, blood samples will be obtained from participants without cancer, who are considered in high risk for HCC; those subjects will be recruited from outpatient units or from Health Management Organization involved in routine surveillance for HCC in high risk subjects.
Inclusion Criteria - Case Group:
Exclusion Criteria - Case Group:
Inclusion Criteria - Control Group:
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
Exclusion Criteria - Control 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
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
Procedure: Blood collection
Peripheral blood will be collected via routine venipuncture procedure
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
Time frame: 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 develop a molecular blood test that will be able to detect HCC based on change in methylation patterns between HCC and normal hepatic tissue
Time frame: 60 months
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)
Time frame: 60 months
Plan to share: No — No IPD will be share with other researchers. The statistical analysis will be performed by the study sponsor
No publications or documents are linked to this record.
This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Nucleix Ltd.