Back to resultsThe Application of Serum DNA Methylation for Patients With HCC
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Serum DNA methylation
Sponsored by
About this trial
This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring DNA methylation
Eligibility Criteria
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
Sites / Locations
- Ditmanson Medical Foundation Chiayi Christian HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DNA methylation
Arm Description
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.
Outcomes
Primary Outcome Measures
The correlation between serum DNA methylation and HCC recurrence or treatment response
The correlation between serum DNA methylation and HCC recurrence or treatment response
Secondary Outcome Measures
Full Information
NCT ID
NCT05764551
First Posted
February 28, 2023
Last Updated
March 20, 2023
Sponsor
Chiayi Christian Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05764551
Brief Title
The Application of Serum DNA Methylation for Patients With HCC
Official Title
he Application of DNA Methylation for Patients Who Had Hepatocellular Carcinoma With Normal Serum Alpha-fetoprotein
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2023 (Anticipated)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiayi Christian Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
DNA methylation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DNA methylation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum DNA methylation
Intervention Description
Serum DNA methylation
Primary Outcome Measure Information:
Title
The correlation between serum DNA methylation and HCC recurrence or treatment response
Description
The correlation between serum DNA methylation and HCC recurrence or treatment response
Time Frame
96 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Po-Yueh Chen, M.D
Phone
+886-5-2765041
Ext
5275
Email
hdilwy7@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chia-Yi Chen, M.D
Phone
+886-5-2765041
Ext
8636
Email
cych12497@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Po-Yueh Chen, M.D
Organizational Affiliation
Ditmanson Medical Foundation Chiayi Christian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ditmanson Medical Foundation Chiayi Christian Hospital
City
Chiayi City
ZIP/Postal Code
600
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Po-Yueh Chen, MD
Phone
+8862765041
Ext
5275
Email
hdilwy7@gmail.com
First Name & Middle Initial & Last Name & Degree
Po-Yueh Chen, MD
First Name & Middle Initial & Last Name & Degree
Chi-Yi Chen, MD
First Name & Middle Initial & Last Name & Degree
Chu-Kuang Chou, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Application of Serum DNA Methylation for Patients With HCC
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