NCT03493763

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
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	5hmC 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).

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-12-31
• Completion: 2020-03-30
• First posted: 2018-04-10
• Last updated: 2018-04-10

Locations

1 site across 1 country: China