HCC Screening Using DNA Methylation Changes in ctDNA

Last updated: July 2, 2024
Sponsor: HKGepitherapeutics
Overall Status: Completed

Phase

N/A

Condition

Liver Cancer

Abdominal Cancer

Liver Disorders

Treatment

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

Clinical Study ID

NCT03483922
HKG-Bng-HCC-100
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 403
Treatment Group(s): 1
Primary Treatment: ctDNA methylation in and it's Correlation wth Development and prediction of HCC
Phase:
Study Start date:
August 20, 2018
Estimated Completion Date:
November 01, 2020

Connect with a study center

  • Infectious Diseases Division

    Dhaka,
    Bangladesh

    Site Not Available

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