Hepatocellular Carcinoma RecurrentNCT05990959
Risk Factors, Prognosis, and Potential Chemoprevention Drugs in Patients With Recurrent Hepatocellular Carcinoma After Curative Surgeries: a Nationwide Retrospective Cohort Study and a Multi-center Prospective Cohort Analysis
An observational study of Hepatocellular Carcinoma Recurrent and Surgery, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Backgrounds: Surgeries are the mainstream of curative therapies for hepatocellular carcinoma (HCC). However, high risk of recurrent HCC after liver surgeries is still the unsolved clinical issue (early recurrence 21% per year; late recurrence 18% per year). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma Recurrent, Surgery
- How many people
- 800 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Apr 2022to 31 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All HCC surgical patients aged more than 20 year-old who sign informed consent for donating remnant tissue or blood after liver surgeries that would be performed under best clinical judgment, NOT for research purpose.
Who may be able to join
- All HCC surgical patients aged more than 20 year-old who sign informed consent for donating remnant tissue or blood after liver surgeries
Who cannot join
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital, Department of Surgery
Taichung, 404
Chun-Chieh Yeh, Dr., +886-975681449, Transplantyeh@gmail.com
About this study
Backgrounds: Surgeries are the mainstream of curative therapies for hepatocellular carcinoma (HCC). However, high risk of recurrent HCC after liver surgeries is still the unsolved clinical issue (early recurrence 21% per year; late recurrence 18% per year). Early recurrence mainly result from disseminated HCC; by contrast, late recurrence usually originate from carcinogenic microenvironment. Currently, no large-scale nationwide studies that integrate laboratory date and clinical information was performed to investigate risk factors and prognosis of post-operative recurrent HCC. Besides, owing to economic issue, few companies would initiate pharmacologic studies to investigate chemoprevention agents for HCC. Furthermore, few biomarkers were discovered from Taiwanese HCC cohort to predict post-operative tumor recurrence because of no standardized cooperative platforms to share biological tissue and clinical information. Therefore, we wish to utilize a nationwide retrospective cohort from integrated national health insurance database (NHIRD) and a prospective multi-center clinical cohort study to address aforementioned issues.
Aims:
- Investigate risk factors and prognosis of post-operative recurrent HCC in Taiwanese cohort
- Discover chemoprevention targets from generic drugs to reduce risk of post-operative recurrent HCC
- Determine biomarkers from Taiwanese cohort in prediction of post-operative recurrent HCC
Read the detailed description
Study subject and methods:
Nationwide retrospective cohort study
- Establish prediction models for postoperative recurrent HCC by analyzing surgical HCC patients' clinical information and perioperative laboratory date based on the database of a nationwide retrospective cohort organized by the Ministry of Health and Welfare and Health insurance office
- Discover chemoprevention agents in association with reduced risk of post-operative recurrent HCC using the aforementioned database
Multicenter prospective cohort study:
- To discover biomarkers in prediction of post-operative recurrent HCC , we will establish a shared platform to prospectively and systemically collect Taiwanese HCC surgical patients' bio-materials and clinical information from China Medical University Hospital, Asian University Hospital, Mackay Hospital, Taichung Veterans General Hospital, E-Da Hospital,…etc.
- Using the multicenter prospective cohort, we could validate the results from the nationwide retrospective cohort study, and even improve the prediction models by adding biological parameters that are not available in the nationwide retrospective cohort
Hospital biobank based retrospective case-control study Investigate clinical and biological parameters in prediction of tumor recurrence in HCC surgical patients by hospital based biobank and relevant clinical information
Laboratory in-vivo and in-vitro study Investigate causal relationship between prognosis of HCC and selected biomarkers from above studies as well as four universal tumor theragnostic markers (ADAM9, MTHFD2, RRM2, and SLC2A1) and explore treatment effects of corresponding inhibitors
Expected results: For scientists, they may benefit from the shared database of Taiwanese HCC surgical patients for the HCC related researches; for physicians, they could predict risk of post-operative recurrent HCC in Taiwanese HCC patients and use generic drugs as potentially chemopreventive drugs for HCC; for patients, they could benefit from the personalized medical advice to increase the survival; for the authorities, they could design a policy to reduce the risk of post-operative recurrent HCC, and even prolong HCC patients' survival in a cost-effective way by using generic drugs as chemopreventive regimens for HCC.
- Conditions
- Hepatocellular Carcinoma Recurrent, Surgery
- Being tested
- No intervention for research purpose
- Keywords
- hepatocellular carcinoma, Recurrent, Surgery, Chemoprevention, National Health Insurance Research Database
- Medical subject headings
- Carcinoma, Hepatocellular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention for research purposeOther
No any intervention will be applied under research purpose. All procedure or drugs would be given to the patient under best clinical judgment, not for research purpose.
| Study group | Role | What they receive |
|---|---|---|
| HCC_surg | HCC surgical patients who would receive surgical interventions based on clinical judgment and would donate biospecimen for research after signing informed consent permission. Receives: Other: No intervention for research purpose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival
Measured: 5 year
Disease free survival
Disease free survival
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start22 Apr 2022
- Primary completionDec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma RecurrentStudies of the same condition, open and under way.
- More trials run by China Medical University 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Responsible party
- Principal investigator, Chun Chieh Yeh, China Medical University Hospital
- Investigators
- Chun-Chieh Yeh, Dr., Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990959
- Sponsor's protocol ID
- CMUH111-REC2-039
- Status last verified
- Aug 2023
- First submitted
- 5 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All patient's privacy would be protected under our IRB regulation. Thus, I cannot release IPD.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors, Prognosis, and Potential Chemoprevention Drugs in Patients With Recurrent Hepatocellular Carcinoma After Curative Surgeries: a Nationwide Retrospective Cohort Study and a Multi-center Prospective Cohort Analysis
- ClinicalTrials.gov ID
- NCT05990959
- Acronym / sponsor ID
- CMUH111-REC2-039
- Conditions
- Hepatocellular Carcinoma Recurrent, Surgery
- Keywords
- hepatocellular carcinoma, Recurrent, Surgery, Chemoprevention, National Health Insurance Research Database
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Aug 2023 (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.
Backgrounds: Surgeries are the mainstream of curative therapies for hepatocellular carcinoma (HCC). However, high risk of recurrent HCC after liver surgeries is still the unsolved clinical issue (early recurrence 21% per year; late recurrence 18% per year). Early recurrence mainly result from disseminated HCC; by contrast, late recurrence usually originate from carcinogenic microenvironment. Currently, no large-scale nationwide studies that integrate laboratory date and clinical information was performed to investigate risk factors and prognosis of post-operative recurrent HCC. Besides, owing to economic issue, few companies would initiate pharmacologic studies to investigate chemoprevention agents for HCC. Furthermore, few biomarkers were discovered from Taiwanese HCC cohort to predict post-operative tumor recurrence because of no standardized cooperative platforms to share biological tissue and clinical information. Therefore, we wish to utilize a nationwide retrospective cohort from integrated national health insurance database (NHIRD) and a prospective multi-center clinical cohort study to address aforementioned issues.
Aims:
- Investigate risk factors and prognosis of post-operative recurrent HCC in Taiwanese cohort
- Discover chemoprevention targets from generic drugs to reduce risk of post-operative recurrent HCC
- Determine biomarkers from Taiwanese cohort in prediction of post-operative recurrent HCC
Detailed description
Study subject and methods:
Nationwide retrospective cohort study
- Establish prediction models for postoperative recurrent HCC by analyzing surgical HCC patients' clinical information and perioperative laboratory date based on the database of a nationwide retrospective cohort organized by the Ministry of Health and Welfare and Health insurance office
- Discover chemoprevention agents in association with reduced risk of post-operative recurrent HCC using the aforementioned database
Multicenter prospective cohort study:
- To discover biomarkers in prediction of post-operative recurrent HCC , we will establish a shared platform to prospectively and systemically collect Taiwanese HCC surgical patients' bio-materials and clinical information from China Medical University Hospital, Asian University Hospital, Mackay Hospital, Taichung Veterans General Hospital, E-Da Hospital,…etc.
- Using the multicenter prospective cohort, we could validate the results from the nationwide retrospective cohort study, and even improve the prediction models by adding biological parameters that are not available in the nationwide retrospective cohort
Hospital biobank based retrospective case-control study Investigate clinical and biological parameters in prediction of tumor recurrence in HCC surgical patients by hospital based biobank and relevant clinical information
Laboratory in-vivo and in-vitro study Investigate causal relationship between prognosis of HCC and selected biomarkers from above studies as well as four universal tumor theragnostic markers (ADAM9, MTHFD2, RRM2, and SLC2A1) and explore treatment effects of corresponding inhibitors
Expected results: For scientists, they may benefit from the shared database of Taiwanese HCC surgical patients for the HCC related researches; for physicians, they could predict risk of post-operative recurrent HCC in Taiwanese HCC patients and use generic drugs as potentially chemopreventive drugs for HCC; for patients, they could benefit from the personalized medical advice to increase the survival; for the authorities, they could design a policy to reduce the risk of post-operative recurrent HCC, and even prolong HCC patients' survival in a cost-effective way by using generic drugs as chemopreventive regimens for HCC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCC_surg | – | Other: No intervention for research purposeHCC surgical patients who would receive surgical interventions based on clinical judgment and would donate biospecimen for research after signing informed consent permission. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All HCC surgical patients aged more than 20 year-old who sign informed consent for donating remnant tissue or blood after liver surgeries that would be performed under best clinical judgment, NOT for research purpose.
Key inclusion criteria (1 listed)
- All HCC surgical patients aged more than 20 year-old who sign informed consent for donating remnant tissue or blood after liver surgeries
Key exclusion criteria (1 listed)
- Pregnant 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 |
|---|---|---|
| No intervention for research purposeNo any intervention will be applied under research purpose. All procedure or drugs would be given to the patient under best clinical judgment, not for research purpose. | Other | HCC_surg |
Primary outcome
Overall survival
Time frame: 5 year
Overall survival
Disease free survival
Time frame: 5 year
Disease free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No. All patient's privacy would be protected under our IRB regulation. Thus, I cannot release IPD.
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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.
Chun-Chieh Yeh, Dr. principal investigator
China Medical University 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 Recurrent and Surgery, run by China Medical University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 14 Aug 2023. 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 Taiwan. 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 Chun-Chieh Yeh, Dr. (886975681449, Transplantyeh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 year). The study lists 2 primary outcomes in all. 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 14 Aug 2023.