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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
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

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.

Condition or disease Intervention/treatment
Hepatocellular Carcinoma Diagnostic Test: 5hmC profile in plasma cell-free DNA after liver resection

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.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

Group/Cohort Intervention/treatment
serum AFP negative HCC patients
  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.
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).




Primary Outcome Measures :
  1. Time of hepatocellular carcinoma recurrence [ Time Frame: 2 years ]
    Time from the day of liver resection to the day of clinical diagnosis of recurrence


Secondary Outcome Measures :
  1. 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.

  2. Serum alpha-fetoprotein level after liver resection [ Time Frame: 2 years or until tumor recurrence ]
  3. 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
plasma cell-free DNA (cfDNA)


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The population will be selected from patients who have received liver resection in the Liver Surgery Department of Zhongshan hospital.
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Jia Fan, MD&PhD +86 21 64041990 fan.jia@zs-hospital.sh.cn

Locations
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China, Shanghai
Zhongshan Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Jia Fan, MD&PhD    +86 21 64041990    fan.jia@zs-hospital.sh.cn   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Study Director: Jia Fan, MD&PhD Shanghai Zhongshan Hospital

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03493763     History of Changes
Other Study ID Numbers: 5hmc HCC monitoring
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shanghai Zhongshan Hospital:
Recurrence Monitoring
5-Hydroxymethylcytosine
Liquid biopsy
Cell-free DNA

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Disease Attributes
Pathologic Processes