Single-Cell Profiling of Liver-infiltrating Immune Cells of Patients with NASH- and Virus-related HCC: Implications for Immunotherapy

NCT06899763 | Completed

• 1 other identifier: 1003rcr2022_72
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the the immune landscape of HCC arising from different etiology, such as MASLD and viral hepatitis, at single cell level. The main question it aims to answer is: Which are the immune signatures and pathways linked to MASLD- or virus-related HCC and what could be the best targets for immunotherapy?

Conditions

Hepatocellular Carcinoma (HCC); MASLD-HCC; HCV_HCC

Keywords

hepatocellular carcinoma; MASLD; HCV

Outcome Measures

Primary Outcomes (1)

• Identification of differentially expressed genes (DEGs) among different patients in the various cellular clusters identified, using scRNA-seq.

  scRNA-seq will provide data to perform cell type annotation. For each cluster DEG will be identify through bioinformatic analysis

  until the end of the study, approximatively 2 years

Study Arms (2)

patients with MASLD-related HCC

The cohort is composed of patients with MASLD-related HCC. MASLD, previously termed non-alcoholic fatty liver disease (NAFLD), is defined as steatotic liver disease (SLD) in the presence of one or more cardiometabolic risk factor(s) and the absence of harmful alcohol intake (Rinella ME, Lazarus JV, Ratziu V, et al. A multisociety Delphi consensus statement on new fatty liver disease nomenclature. J Hepatol. 2023;79(6):1542-1556. doi:10.1016/j.jhep.2023.06.003).

patients with HCV-related HCC

The cohort is composed of patients with HCV-related HCC.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of MASLD-related HCC or HCV-related HCC

You may qualify if:

• HCV-related HCC or MASLD-related HCC
• age: ≥ 18 years, ≤ 90 years
• Signature of the informed consent
• Esclusion criteria:
• Concomitant pathologies with a life expectancy of less than 12 months
• Autoimmune or chronic inflammatory diseases
• Treatment with atezolizumab, bevacizumab, sorafenib, lenvatinib, regorafenib, cabozantinib, checkpoint inhibitors, tyrosine kinase inhibitors, or anti-VEGF therapies
• Other ongoing extrahepatic malignancies or those diagnosed within the last 3 years, except for tumors resected with curative intent and with no evidence of disease recurrence for \>3 years prior to the signing of informed consent, and considered at low risk of recurrence
• HIV infection
• Lack of patient cooperation and failure to sign the informed consent

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Pavia, 27100, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and peripheral blood mononuclear cells

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 28, 2025
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)