HCC Screening Using DNA Methylation Changes in ctDNA

HKG Epitherapeutics

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Diagnostic Test: ctDNA methylation in and it's Correlation wth Development and prediction of HCC

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03483922

HKG-Bng-HCC-100

Details and patient eligibility

About

Hepatocellular Carcinoma (HCC) is the fifth most common cancer world-wide. It is particularly prevalent in Asia, and its occurrence is highest in areas where hepatitis B is prevalent, indicating a possible causal relationship. Follow up of high-risk populations such as chronic hepatitis patients and early diagnosis of transitions from chronic hepatitis to HCC would improve cure rates. In most cases HCC is detected late resulting in increased mortality and morbidity.

The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in PBMC and circulated tumor DNA in hepatocellular carcinomas patients.

Enrollment: 403 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Confirmed diagnosis of HCC by EASL-EORTC guidelines
• Confirmed hepatitis B diagnosis for HepB patients using AASLD practice guidelines.

Exclusion Criteria for HCC:

• Cirrhosis, any other known inflammatory disease (bacterial or viral infection with the exception of hepatitis B or C, diabetes, asthma, autoimmune disease, active thyroid disease) which could alter T cells and monocytes characteristics
• Other cancers.

Exclusion Criteria for HepB:

• Diagnosis of HCC or any other cancer.

Exclusion Criteria for Healthy Controls:

• Any known inflammatory or infectious disease including HepB and HepC
• Chronic diseases,
• Cancer
• Medications or drug use

Trial design

403 participants in 3 patient groups

chronic hepatitis B

Description:

This group will include 50 with hepatitis B subjects and the diagnoses will be based on AASLD practice guideline.

Treatment:

Diagnostic Test: ctDNA methylation in and it's Correlation wth Development and prediction of HCC

HCC Cases

Description:

This group will include 350 in stage 0, stage A, stage B, Stage C+D of hepatocellular carcinoma. HCC staging will be diagnosed according to EASL-EORTC Clinical Practice Guidelines: Management of hepatocellular carcinoma

Treatment:

Diagnostic Test: ctDNA methylation in and it's Correlation wth Development and prediction of HCC

Healthy

Description:

This group will include 50 healthy sex and age matched controls.

Treatment:

Diagnostic Test: ctDNA methylation in and it's Correlation wth Development and prediction of HCC