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Trial Title:
Dissection of the Molecular and Immunological Interaction in Patients With HCC of Viral and Non-viral Etiologies
NCT ID:
NCT05613621
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
Hepatocellular Carcinoma
next-generation sequencing
precision medicine
Study type:
Observational
Overall status:
Enrolling by invitation
Study design:
Time perspective:
Prospective
Summary:
This project will clarify the potential interaction between HBV infection and steatosis,
and their impact on genetic alterations and tumor immune microenvironment.
Detailed description:
This study will start with a "training cohort" of the NTUH and NTU Cancer Center
patients, consisting of 4 sub-groups: HBV (+) steatosis (+), HBV (-) steatosis (+), HBV
(+) steatosis (-) and HBV (-) steatosis (-). HBV (+) is defined as either: (a) HBsAg (+)
or (b) HBsAg (-) anti-HBc (+) and HBV DNA detectable in blood or tumor tissue. Steatosis
is defined by histology. We will enroll 400 patients who had sufficient tissue for
testing in the training cohort. The following studies will be performed: (1) NGS of
targeted genes panel using the National Health Research Institutes precision medicine
platform; (2) transcriptomic analysis of immune microenvironment using RNA-seq and
multiplex immunofluorescence staining; (3) lipotoxic genotyping for SNPs; (4) clinical
outcomes of MAFLD vs. non-MAFLD. The genetic and immunological features will be further
tested by a "validation cohort", from collaborative hospitals. This project will clarify
the potential interaction between HBV infection and steatosis, and their impact on
genetic alterations and tumor immune microenvironment.
Criteria for eligibility:
Study pop:
hepatocellular carcinoma patients
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Adult female or male patients aged ≥20 years.
2. HCC has been histologically confirmed with resection specimen.
3. The surgery should be performed with curative intent after 2015 in the study
hospital.
4. Availability of serum HBsAg and Anti-HBc data in the electronic medical record.
5. Availability of imaging data performed within 3 months before the surgery in the
electronic medical record. (at least one of the following: computed tomography,
magnetic resonance imaging, abdominal sonography).
6. Informed consent is obtained. Willingness to provide the residual operative slides
and medical records.
Exclusion Criteria:
1. Fibrolamellar HCC, sarcomatoid HCC, or a mixture of cholangiocarcinoma and HCC
2. Exclusion of HCV patients (Anti-HCV positive)
3. Inability to cooperate by providing a complete medical history.
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cheng-Kung University Hospital
Address:
City:
Tainan
Country:
Taiwan
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Facility:
Name:
Mackay Memorial Hospital
Address:
City:
Taipei
Country:
Taiwan
Facility:
Name:
National Taiwan University Cancer Center
Address:
City:
Taipei
Country:
Taiwan
Start date:
November 23, 2022
Completion date:
December 31, 2026
Lead sponsor:
Agency:
National Health Research Institutes, Taiwan
Agency class:
Other
Collaborator:
Agency:
National Taiwan University Hospital
Agency class:
Other
Collaborator:
Agency:
Mackay Memorial Hospital
Agency class:
Other
Collaborator:
Agency:
National Cheng-Kung University Hospital
Agency class:
Other
Source:
National Health Research Institutes, Taiwan
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05613621
