N/A Completed N=402

HCC Screening Using DNA Methylation Changes in ctDNA

Hepatocellular Carcinoma

Source: ClinicalTrials.gov NCT03483922 ↗

Enrolled (actual)

402

Serious AEs

—

Results posted

Jul 2024

Primary outcomePrimary: Calculation of M Scores and HCC Probability Scores — 1.113; 1.159; 1.797; 1.707 units on a scale

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Calculation of M Scores and HCC Probability Scores	1.113; 1.159; 1.797; 1.707; 1.839; 1.818	—

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,
Cancer
Medications or drug use

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03483922). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.