Characterization of Methylation Patterns in Hepatocellular Carcinoma
NCT ID: NCT04264754
Last Updated: 2021-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
120 participants
OBSERVATIONAL
2018-02-13
2021-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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)
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:
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
Blood collection
Peripheral blood will be collected via routine venipuncture procedure
Interventions
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Blood collection
Peripheral blood will be collected via routine venipuncture procedure
Eligibility Criteria
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Inclusion Criteria
* Subjects who are willing and able to provide written informed consent
* Subjects with confirmed diagnosis of HCC, naïve to tumor directed therapy
* 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 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
* 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
22 Years
ALL
No
Sponsors
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Nucleix Ltd.
INDUSTRY
Responsible Party
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Locations
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Ha'emek Medical Center
Afula, , Israel
Carmel Medical Center
Haifa, , Israel
Rambam Medical Center
Haifa, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Other Identifiers
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Liver-RND-001
Identifier Type: -
Identifier Source: org_study_id
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