The Application of Serum DNA Methylation for Patients With HCC

he Application of DNA Methylation for Patients Who Had Hepatocellular Carcinoma With Normal Serum Alpha-fetoprotein

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05764551

Enrollment

100

Registered

2023-03-10

Start date

2023-03-28

Completion date

2026-03-31

Last updated

2023-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

DNA methylation

Brief summary

The goal of this single-arm prospective study is to evaluate the application of serum DNA methylation for HCC patients with normal alpha-fetoprotein. The main question it aims to answer is . Is the dynamic change of serum DNA methylation correlated to recurrence or treatment response of HCC

Detailed description

The enrolled individuals with HCC and normal serum alpha-fetoprotein level would receive serum DNA methylation test before their treatment (including all kinds of recommened HCC treatment). Then regularly serum DNA methylation test would be done at 4th\ 8th weeks, 16th week, 32th week and 48th week. If the enrolled patients did not have HCC recurrence during at 48th week. The regular check of serum DNA methylation would be canceled. The enrolled patients would be observed till 96th week. If there is any recurrence during 48\ 96th week, one time of serum DNA methylation would be checked at the time of recurrence. The observation and intervention would be completed at 96th week.

Interventions

DIAGNOSTIC_TESTSerum DNA methylation

Serum DNA methylation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥ 20 years old * The diagnosis of hepatocellular carcinoma (HCC) according to AASLD 2018 clinical guidelines or histology report * Individuals with HCC and normal serum alpha-fetorpotein level (\<20 ng/ml) * Individuals who could sign informed consent

Exclusion criteria

* The histology report revealed non-HCC, HCC mixed with cholangiocarcinoma or sarcomatoid HCC * Individuals with HCC and other concurrent malignancies * Individuals with chronic kidney disease who could not tolerate contrast-enhanced dynamic images * Individuals ever receiving any organ transplantation * Individuals with HIV infection * Individuals who could not able to understand and sign informed consent

Design outcomes

Primary

Measure	Time frame	Description
The correlation between serum DNA methylation and HCC recurrence or treatment response	96 weeks	The correlation between serum DNA methylation and HCC recurrence or treatment response

Countries

Taiwan

Contacts

Primary ContactPo-Yueh Chen, M.D

hdilwy7@gmail.com+886-5-2765041

Backup ContactChia-Yi Chen, M.D

cych12497@gmail.com+886-5-2765041

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026