Clinical trial NCT04264754: Characterization of Methylation Patterns in Hepatocellular Carcinoma
Official title: Characterization of Methylation Patterns in Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatocellular Carcinoma
Hepatocellular Cancer
Cirrhosis
Keywords: Cirrhosis
Hepatocellular Carcinoma
Methylation
HCC
Lead sponsor: Nucleix Ltd.
Sponsor class: INDUSTRY
First posted: 2020-02-11
Enrollment: 120
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria - Case Group:

* Age ≥ 22 years
* Subjects who are willing and able to provide written informed consent
* Subjects with confirmed diagnosis of HCC, naïve to tumor directed therapy

Exclusion Criteria - Case Group:

* 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

Inclusion Criteria - Control Group:

* 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 - Control Group:

* 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

Primary outcomes:
measure: To collect blood samples and clinical data in order to characterize methylation patterns that will discriminate between HCC and normal hepatic tissue
timeFrame: 60 months
measure: 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
timeFrame: 60 months
Secondary outcomes:
measure: Liver EpiCheck Performance
timeFrame: 60 months
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Ha'emek Medical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
References: