Hepatocellular Carcinoma Liver Organoids (HELIO)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: Liver biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06355700

5476

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Hepatocellular Carcinoma

Experimental group

Description:

Participants undergo to a liver biopsy, a venous blood sampling and a fecal sample collecting

Treatment:

Procedure: Liver biopsy