The Application of Serum DNA Methylation for Patients With HCC

Sponsor

Chiayi Christian Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05764551

Collaborator

(none)

100

Enrollment

Arm

36.5

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Diagnostic Test: Serum DNA methylation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Mar 15, 2023

Anticipated Primary Completion Date :

Mar 31, 2025

Anticipated Study Completion Date :

Mar 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Diagnostic Test: Serum DNA methylation Serum DNA methylation

Arm

Intervention/Treatment

Experimental: 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.

Diagnostic Test: Serum DNA methylation

Serum DNA methylation

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Chiayi Christian Hospital

Investigators

Principal Investigator: Po-Yueh Chen, M.D, Ditmanson Medical Foundation Chiayi Christian Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chiayi Christian Hospital

ClinicalTrials.gov Identifier:

NCT05764551

Other Study ID Numbers:

IRB2022051

First Posted:

Mar 10, 2023

Last Update Posted:

Mar 10, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Chiayi Christian Hospital

DNA methylation

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Hepatocellular

Study Results

No Results Posted as of Mar 10, 2023