Using serum DNA methylation to monitor hepatocellular carcinoma
he Application of DNA Methylation for Patients Who Had Hepatocellular Carcinoma With Normal Serum Alpha-fetoprotein
This study is testing if changes in DNA found in blood can help track how well treatment is working for people with liver cancer who have normal alpha-fetoprotein levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Chiayi Christian Hospital Academic / other |
| Locations | 1 site (Chiayi City) |
| Trial ID | NCT05764551 on ClinicalTrials.gov |
What this trial studies
This prospective study aims to evaluate the role of serum DNA methylation in patients with hepatocellular carcinoma (HCC) who have normal alpha-fetoprotein levels. Participants will undergo serum DNA methylation testing before treatment and at regular intervals thereafter to assess changes that may correlate with treatment response or recurrence of HCC. The study will observe patients for up to 96 weeks, with additional testing conducted if recurrence occurs during this period. The goal is to determine the effectiveness of serum DNA methylation as a biomarker for HCC management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 and older diagnosed with hepatocellular carcinoma and normal serum alpha-fetoprotein levels.
Not a fit: Patients with non-HCC diagnoses, concurrent malignancies, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive method for monitoring HCC recurrence and treatment response.
How similar studies have performed: While the application of serum DNA methylation is a novel approach in this context, similar studies have shown promise in other cancer types.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chiayi City
- Ditmanson Medical Foundation Chiayi Christian Hospital — Chiayi City, Taiwan (Recruiting)
Study contacts
- Principal investigator: Po-Yueh Chen, M.D — Ditmanson Medical Foundation Chiayi Christian Hospital
- Study coordinator: Po-Yueh Chen, M.D
- Email: hdilwy7@gmail.com
- Phone: +886-5-2765041
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.