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Study on Recurrence Monitoring of Hepatocellular Carcinoma With 5-Hydroxymethylcytosine Test

Study on Recurrence Monitoring of Hepatocellular Carcinoma With 5-Hydroxymethylcytosine Based on hmC-Seal Technology

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03493763
Enrollment
300
Registered
2018-04-10
Start date
2018-03-01
Completion date
2020-03-30
Last updated
2018-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

Recurrence Monitoring, 5-Hydroxymethylcytosine, Liquid biopsy, Cell-free DNA

Brief summary

In this study, investigators aim to find out how plasma 5hmC level changes in hepatocellular carcinoma patients after liver resection, and determine whether 5hmC can be used as a biomarker for HCC recurrence monitoring.

Detailed description

Hepatocellular carcinoma (HCC) is the most common primary liver cancer and the third leading cause of cancer-related death worldwide. Liver resection is a common treatment for HCC. However, even after successful surgical resection, most patients suffered from recurrence or progression of the tumor. Because clinical staging systems cannot precisely predict the outcome of patients with HCC, it's of great interest to search biomarkers for HCC. Among them, alpha-fetoprotein (AFP) is the most well-studied. However, the applicability of AFP for HCC after surgical resection of tumor is still uncertain. The discovery of cell-free DNA (cfDNA) originating from different tissues in the circulating blood has revolutionary potential for the clinic. Liquid biopsy-based biomarkers and detection tools offer substantial advantages over existing diagnostic and prognostic methods, including being minimally invasive. They thus have a cost-efficient potential to promote higher patient compliance and clinical convenience to enable dynamic monitoring. 5-hydroxymethylcytosine (5hmC) is the intermediate of active demethylation from 5-methylcytosine. 5hmC not only marks active demethylation but also serves as a relatively stable DNA mark that plays distinct epigenetic roles. Recent genome-wide sequencing maps of 5hmC in various mammalian cells and tissues support its role as a marker for gene expression. Previous studies have established 5hmC-Seal technology for 5hmC profiling in cfDNA and showed that the differentially enriched 5hmC regions in cfDNA are excellent markers for solid tumors. In this study, investigators aim to find out how plasma 5hmC profile changes in hepatocellular carcinoma patients after liver resection, and determine whether 5hmC can be used as a biomarker for HCC recurrence monitoring.

Interventions

DIAGNOSTIC_TEST5hmC profile in plasma cell-free DNA after liver resection

Peripheral blood is drawn every 3 months after liver resection for 5hmC test (Time frame: 2 years or until tumor recurrence).

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

1. Patients who received liver resection within 3 months; 2. Hepatocellular carcinoma confirmed pathologically; 3. Serum alpha-fetoprotein level lower than 20ng/ml before hepatectomy.

Exclusion criteria

1. Patients with macroscopic tumor remnants; 2. Patients with other diseases which may affect the observation mentioned here; 3. Patients with medical history of other malignant tumors; 4. Pregnant or nursing women.

Design outcomes

Primary

MeasureTime frameDescription
Time of hepatocellular carcinoma recurrence2 yearsTime from the day of liver resection to the day of clinical diagnosis of recurrence

Secondary

MeasureTime frameDescription
5hmC level in recurrence-related cfDNA after liver resection2 years or until tumor recurrencePeripheral blood is drawn every 3 months after liver resection. 5hmc level in cfDNA in particular recurrence-related genes is tested by cfDNA sequencing and calculated by feature counts.
Serum alpha-fetoprotein level after liver resection2 years or until tumor recurrence
Adverse effect of 5hmC blood test2 yearsAny adverse effect of the test is to be recorded.

Countries

China

Contacts

Primary ContactJia Fan, MD&PhD
fan.jia@zs-hospital.sh.cn+86 21 64041990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026