Study on Recurrence Monitoring of Hepatocellular Carcinoma With 5-Hydroxymethylcytosine Test
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|ClinicalTrials.gov Identifier: NCT03493763|
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : April 10, 2018
|Condition or disease||Intervention/treatment|
|Hepatocellular Carcinoma||Diagnostic Test: 5hmC profile in plasma cell-free DNA after liver resection|
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.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Study on Recurrence Monitoring of Hepatocellular Carcinoma With 5-Hydroxymethylcytosine Based on hmC-Seal Technology|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||March 30, 2020|
serum AFP negative HCC patients
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).
- Time of hepatocellular carcinoma recurrence [ Time Frame: 2 years ]Time from the day of liver resection to the day of clinical diagnosis of recurrence
- 5hmC level in recurrence-related cfDNA after liver resection [ Time Frame: 2 years or until tumor recurrence ]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.
- Serum alpha-fetoprotein level after liver resection [ Time Frame: 2 years or until tumor recurrence ]
- Adverse effect of 5hmC blood test [ Time Frame: 2 years ]Any adverse effect of the test is to be recorded.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493763
|Contact: Jia Fan, MD&PhD||+86 21 firstname.lastname@example.org|
|Shanghai, Shanghai, China, 200032|
|Contact: Jia Fan, MD&PhD +86 21 64041990 email@example.com|
|Study Director:||Jia Fan, MD&PhD||Shanghai Zhongshan Hospital|