Hepatocellular CarcinomaNCT03493763
Study on Recurrence Monitoring of Hepatocellular Carcinoma With 5-Hydroxymethylcytosine Test
An observational study of Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- 5hmC profile in plasma cell-free DNA after liver resection
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 30 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population will be selected from patients who have received liver resection in the Liver Surgery Department of Zhongshan hospital.
Who may be able to join
- Patients who received liver resection within 3 months;
- Hepatocellular carcinoma confirmed pathologically;
- Serum alpha-fetoprotein level lower than 20ng/ml before hepatectomy.
Who cannot join
- Patients with macroscopic tumor remnants;
- Patients with other diseases which may affect the observation mentioned here;
- Patients with medical history of other malignant tumors;
- Pregnant or nursing women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Jia Fan, MD&PhD, +86 21 64041990, fan.jia@zs-hospital.sh.cn
About this study
Official title: Study on Recurrence Monitoring of Hepatocellular Carcinoma With 5-Hydroxymethylcytosine Based on hmC-Seal Technology
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.
Read the 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
- Being tested
- 5hmC profile in plasma cell-free DNA after liver resection
- Keywords
- Recurrence Monitoring, 5-Hydroxymethylcytosine, Liquid biopsy, Cell-free DNA
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5hmC profile in plasma cell-free DNA after liver resectionDiagnostic test
Peripheral blood is drawn every 3 months after liver resection for 5hmC test (Time frame: 2 years or until tumor recurrence).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: 5hmC profile in plasma cell-free DNA after liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of hepatocellular carcinoma recurrence
Time from the day of liver resection to the day of clinical diagnosis of recurrence
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 2 years or until tumor recurrence
Serum alpha-fetoprotein level after liver resection
Measured: 2 years or until tumor recurrence
Adverse effect of 5hmC blood test
Any adverse effect of the test is to be recorded.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start1 Mar 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jia Fan, MD&PhD, Study director, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493763
- Sponsor's protocol ID
- 5hmc HCC monitoring
- Status last verified
- Apr 2018
- First submitted
- 1 Apr 2018
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Recurrence Monitoring of Hepatocellular Carcinoma With 5-Hydroxymethylcytosine Based on hmC-Seal Technology
- ClinicalTrials.gov ID
- NCT03493763
- Acronym / sponsor ID
- 5hmc HCC monitoring
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Recurrence Monitoring, 5-Hydroxymethylcytosine, Liquid biopsy, Cell-free DNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| serum AFP negative HCC patients | – | Diagnostic Test: 5hmC profile in plasma cell-free DNA after liver resection1. Patients who received liver resection within 3 months; 2. Hepatocellular carcinoma confirmed pathologically; 3. Serum alpha-fetoprotein level lower than 20ng/ml before hepatectomy. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will be selected from patients who have received liver resection in the Liver Surgery Department of Zhongshan hospital.
Key inclusion criteria (3 listed)
- Patients who received liver resection within 3 months;
- Hepatocellular carcinoma confirmed pathologically;
- Serum alpha-fetoprotein level lower than 20ng/ml before hepatectomy.
Key exclusion criteria (4 listed)
- Patients with macroscopic tumor remnants;
- Patients with other diseases which may affect the observation mentioned here;
- Patients with medical history of other malignant tumors;
- Pregnant or nursing women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5hmC profile in plasma cell-free DNA after liver resectionPeripheral blood is drawn every 3 months after liver resection for 5hmC test (Time frame: 2 years or until tumor recurrence). | Diagnostic test | serum AFP negative HCC patients |
Primary outcome
Time of hepatocellular carcinoma recurrence
Time frame: 2 years
Time from the day of liver resection to the day of clinical diagnosis of recurrence
3 secondary outcomes
5hmC level in recurrence-related cfDNA after liver resection
Time frame: 2 years or until tumor recurrence
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia Fan, MD&PhD study director
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia Fan, MD&PhD (+86 21 64041990, fan.jia@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of hepatocellular carcinoma recurrence (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.