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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03493763
• Other study ID #: 5hmc HCC monitoring
• Status: Recruiting
• First received: April 1, 2018
• Last updated: April 9, 2018
• Start date: March 1, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: April 2018
• Source: Shanghai Zhongshan Hospital
• Contact: Jia Fan, MD&PhD
• Phone: +86 21 64041990
• Email: fan.jia[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Recurrence

Intervention

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).

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of hepatocellular carcinoma recurrence	Time from the day of liver resection to the day of clinical diagnosis of recurrence	2 years
Secondary	5hmC level in recurrence-related cfDNA after liver resection	Peripheral 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.	2 years or until tumor recurrence
Secondary	Serum alpha-fetoprotein level after liver resection		2 years or until tumor recurrence
Secondary	Adverse effect of 5hmC blood test	Any adverse effect of the test is to be recorded.	2 years