Clinical Trials on Detection of Hepatocellular Carcinoma With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC and T Cells
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- HKGepitherapeutics
- Enrollment
- 403
- Locations
- 1
- Primary Endpoint
- Calculation of M Scores and HCC Probability Scores
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility 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,
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Calculation of M Scores and HCC Probability Scores
Time Frame: 6 months to 1 year
We normalized median methylation values (range 0-100) for 'HCC-detect' (Hepatocellular Carcinoma Detection) and 'HCC-spec' (Hepatocellular Carcinoma Specificity). 'HCC-detect' is derived from CHFR, VASH2, CCNJ, and GRID2IP regions, aiming to broadly identify HCC. Theoretical range is -6.6438 to 8.6438, with observed -3.541 to 7.65; higher scores indicate increased HCC likelihood. 'HCC-spec', focusing on the F12 region, differentiates HCC from 31 other cancers and normal cells, with theoretical range -3.3219 to 6.64385 (observed -3.3219 to 6.6297). Higher scores signify greater HCC specificity. Both scores, modeled via logistic regression in Prism, predict HCC probability, linking higher scores with higher HCC likelihood or specificity