Clinical trial NCT05613621: Dissection of the Molecular and Immunological Interaction in Patients With HCC of Viral and Non-viral Etiologies
Official title: Dissection of the Molecular and Immunological Interaction in Patients With Hepatocellular Carcinoma of Viral and Non-viral Etiologies
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
next-generation sequencing
precision medicine
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital
name: Mackay Memorial Hospital
name: National Cheng-Kung University Hospital
First posted: 2022-11-14
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hepatocellular carcinoma patients

Brief 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.

Eligibility 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.

Primary outcomes:
measure: transcriptomic analysis of immune microenvironment
timeFrame: 2 Years
measure: lipotoxic genotyping for SNPs
timeFrame: 2 years
measure: clinical outcomes of MAFLD vs. non-MAFLD.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Cancer Center
Study officials:
affiliation: Taiwan Cooperative Oncology Group, NHRI
name: Tsang-Wu Liu
role: STUDY_DIRECTOR
References: