The Application of Serum DNA Methylation for Patients With HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05764551
• Other study ID #: IRB2022051
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: February 2023
• Source: Chiayi Christian Hospital
• Contact: Po-Yueh Chen, M.D
• Phone: +886-5-2765041
• Email: hdilwy7[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Diagnostic Test:
• Serum DNA methylation
Serum DNA methylation

Locations

Country	Name	City	State
Taiwan	Ditmanson Medical Foundation Chiayi Christian Hospital	Chiayi City

Sponsors (1)

Lead Sponsor	Collaborator
Chiayi Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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