The Application of Serum DNA Methylation for Patients With HCC
he Application of DNA Methylation for Patients Who Had Hepatocellular Carcinoma With Normal Serum Alpha-fetoprotein
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hepatocellular-carcinoma
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2023
CompletedFirst Posted
Study publicly available on registry
March 10, 2023
CompletedStudy Start
First participant enrolled
March 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedMarch 21, 2023
February 1, 2023
2 years
February 28, 2023
March 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
DNA methylation
EXPERIMENTALThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ditmanson Medical Foundation Chiayi Christian Hospital
Chiayi City, 600, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Po-Yueh Chen, M.D
Ditmanson Medical Foundation Chiayi Christian Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2023
First Posted
March 10, 2023
Study Start
March 28, 2023
Primary Completion
March 31, 2025
Study Completion
March 31, 2026
Last Updated
March 21, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share