Hepatocellular Carcinoma Liver Organoids

Not Applicable

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: Liver biopsy

• Registration Number: NCT06355700
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

The goal of this interventional study is to create hepatocellular carcinoma organoids from liver bioptic samples of individuals with hepatocellular carcinoma. The main questions it aims to answer are:

* the feasibility of hepatocellular carcinoma organoids integrated with host gut microbiota and peripheral blood mononuclear cells

* the molecular pattern of the organoid tumor microenvironment

* the in vitro therapeutic response of hepatocellular carcinoma organoids

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-13
• Study Start: 2023-06-15
• Status Verified: 2024-03
• Study First Submitted QC: 2024-04-03
• Last Update Submitted: 2024-04-03
• Study First Posted: 2024-04-09
• Last Update Posted: 2024-04-09
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Ability to express informed consent
• Patients ≥ 18 years of age
• Radiological diagnosis of hepatocellular carcinoma (HCC)

Exclusion Criteria

• Patients <18 years of age
• Contraindications for liver biopsy: ascites, platelet count <50.000, International Normalized Ratio (INR) >1.7
• Active viral infection
• Refusal to give informed consent for the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hepatocellular Carcinoma	Liver biopsy	Participants undergo to a liver biopsy, a venous blood sampling and a fecal sample collecting

Primary Outcome Measures

Name	Time	Method
Success rate of hepatocellular carcinoma organoids integrated with host gut microbiota and peripheral blood mononuclear cells	within 12 months	Number of successfully created organoids from all hepatocellular carcinoma samples

Secondary Outcome Measures

Name	Time	Method
Evaluation of the concordance of somatic genetic mutations between the organoid and the original tumor	within 12 months	DNA organoids and original tumor sample sequencing and comparison between the somatic genetic mutations found in both models
Correlation between gut microbiota community profiling and growth rate of hepatocellular carcinoma organoids	within 12 months	Definition of microbiota composition via DNA and RNA sequencing and correlation between specific bacteria abundance and successful organoids growth
Treatment response evaluation in vitro	Day 5	Evaluation of organoids' tumor cells survival after 5 days of chemotherapy treatment.; Treatment will include different concentrations of sorafenib, lenvatinib, atezolizumab, bevacizumab, tremelimumab, durvalumab, regorafenib, cabozantinib. Tumor cells vitality will be assessed trough Cell TitelGlo3D Cell Viability Assay.
Analysis of hepatocellular carcinoma organoid transcriptome distribution within a reference set from The Cancer Genome Atlas	within 12 months	Comparison between organoids transcriptome and data from The Cancer Genome Atlas

Trial Locations

Locations (1)

Fondazione Policlinico Agostino Gemelli IRCCS; 🇮🇹 Roma, Italy