The Application of Serum DNA Methylation for Patients With HCC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-28

Study Completion Date

2026-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Serum DNA methylation

Intervention Type DIAGNOSTIC_TEST

Serum DNA methylation

Interventions

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Serum DNA methylation

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No