Dissection of the Molecular and Immunological Interaction in Patients With HCC of Viral and Non-viral Etiologies

Hepatocellular Carcinoma Clinical Trial

— T4222  

Official title:

Dissection of the Molecular and Immunological Interaction in Patients With Hepatocellular Carcinoma of Viral and Non-viral Etiologies

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05613621
• Other study ID #: T4222
• Status: Not yet recruiting
• Start date: November 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2022
• Source: National Health Research Institutes, Taiwan
• Contact: Bor-Rong Chen
• Phone: 886-2-26534401
• Email: brong[@]nhri.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This project will clarify the potential interaction between HBV infection and steatosis, and their impact on genetic alterations and tumor immune microenvironment.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
Taiwan	National Cheng-Kung University Hospital	Tainan
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (4)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan	Mackay Memorial Hospital, National Cheng-Kung University Hospital, National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	transcriptomic analysis of immune microenvironment	using RNA-seq and multiplex immunofluorescence staining	2 Years
Primary	lipotoxic genotyping for SNPs	lipotoxic genotyping for SNPs	2 years
Primary	clinical outcomes of MAFLD vs. non-MAFLD.	clinical outcomes of MAFLD vs. non-MAFLD.	2 years