The Application of Serum DNA Methylation for Patients With HCC

Not Applicable

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Diagnostic Test: Serum DNA methylation

• Registration Number: NCT05764551
• Lead Sponsor: Chiayi Christian Hospital

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.

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-10
• Last Update Submitted: 2023-03-20
• Last Update Posted: 2023-03-21
• Study Start: 2023-03-28
• Primary Completion: 2025-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DNA methylation	Serum DNA methylation	The enrolled individuals with HCC 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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ditmanson Medical Foundation Chiayi Christian Hospital; 🇨🇳 Chiayi City, Taiwan