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Trial 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
NCT ID:
NCT05990959
Condition:
Hepatocellular Carcinoma Recurrent
Surgery
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Recurrence
Conditions: Keywords:
hepatocellular carcinoma
Recurrent
Surgery
Chemoprevention
National Health Insurance Research Database
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
No intervention for research purpose
Description:
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.
Arm group label:
HCC_surg
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).
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:
1. Investigate risk factors and prognosis of post-operative recurrent HCC in Taiwanese
cohort
2. Discover chemoprevention targets from generic drugs to reduce risk of post-operative
recurrent HCC
3. Determine biomarkers from Taiwanese cohort in prediction of post-operative recurrent
HCC
Detailed description:
Study subject and methods:
Nationwide retrospective cohort study
1. 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
2. Discover chemoprevention agents in association with reduced risk of post-operative
recurrent HCC using the aforementioned database
Multicenter prospective cohort study:
1. 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.
2. 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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- All HCC surgical patients aged more than 20 year-old who sign informed consent for
donating remnant tissue or blood after liver surgeries
Exclusion Criteria:
- Pregnant women
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
China Medical University Hospital, Department of Surgery
Address:
City:
Taichung
Zip:
404
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chun-Chieh Yeh, Dr.
Phone:
+886-975681449
Email:
Transplantyeh@gmail.com
Start date:
April 22, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
China Medical University Hospital
Agency class:
Other
Collaborator:
Agency:
Ministry of Health and Welfare, Taiwan
Agency class:
Other
Source:
China Medical University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05990959
