The Application of Serum DNA Methylation for Patients With HCC

March 20, 2023 updated by: Chiayi Christian Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Chiayi City, Taiwan, 600
        • Recruiting
        • Ditmanson Medical Foundation Chiayi Christian Hospital
        • Sub-Investigator:
          • Chi-Yi Chen, MD
        • Sub-Investigator:
          • Chu-Kuang Chou, MD
        • Principal Investigator:
          • Po-Yueh Chen, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiayi Christian Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 28, 2023

Primary Completion (Anticipated)

March 31, 2025

Study Completion (Anticipated)

March 31, 2026

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB2022051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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