Characterization of Methylation Patterns in Hepatocellular Carcinoma

NCT04264754 | Terminated

• 1 other identifier: Liver-RND-001
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 5

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

Conditions

Hepatocellular Carcinoma; Hepatocellular Cancer; Cirrhosis

Keywords

Cirrhosis; Hepatocellular Carcinoma; Methylation; HCC

Outcome Measures

Primary Outcomes (2)

• 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

  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

  60 months

Secondary Outcomes (1)

• Liver EpiCheck Performance

  60 months

Study Arms (2)

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)

Procedure: Blood collection

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

Procedure: Blood collection

Interventions

Blood collection PROCEDURE

Peripheral blood will be collected via routine venipuncture procedure

Cases Group; Control Group

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)
• 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

Sponsors & Collaborators

• Nucleix Ltd.: lead

Study Sites (5)

Ha'emek Medical Center

Afula, Israel

Location

Carmel Medical Center

Haifa, Israel

Location

Rambam Medical Center

Haifa, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms; Fibrosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2020
• First Posted: February 11, 2020
• Study Start: February 13, 2018
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: May 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (5)