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Trial Title:
The Application of Serum DNA Methylation for Patients With HCC
NCT ID:
NCT05764551
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
DNA methylation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Serum DNA methylation
Description:
Serum DNA methylation
Arm group label:
DNA methylation
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.
Criteria for 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
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ditmanson Medical Foundation Chiayi Christian Hospital
Address:
City:
Chiayi City
Zip:
600
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Po-Yueh Chen, MD
Phone:
+8862765041
Phone ext:
5275
Email:
hdilwy7@gmail.com
Investigator:
Last name:
Po-Yueh Chen, MD
Email:
Principal Investigator
Investigator:
Last name:
Chi-Yi Chen, MD
Email:
Sub-Investigator
Investigator:
Last name:
Chu-Kuang Chou, MD
Email:
Sub-Investigator
Start date:
March 28, 2023
Completion date:
March 31, 2026
Lead sponsor:
Agency:
Chiayi Christian Hospital
Agency class:
Other
Source:
Chiayi Christian Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05764551
