RecruitingNot ApplicableNCT06355700

Hepatocellular Carcinoma Liver Organoids

Hepatocellular Carcinoma Organoids to Explore Tumor Microenvironment and Test Treatment Efficacy - Hepatocellular Carcinoma Liver Organoids (HELIO)


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

10 participants

Start Date

Jun 15, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria4

  • 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

Interventions

PROCEDURELiver biopsy

The liver biopsy is ultrasound-guided and target the hepatic lesions. It is performed with 18G or 19G Menghini needle. A part of bioptic sample will be used for genomic analysis. An other part of sample will be cultured to create the organoid. The organoid's cultures will be integrated with the host gut microbiota (collected by a fecal sample) and peripheral blood mononuclear cells (from venous blood sample) and they will be used for research such as molecular analysis and pharmacological tests.


Locations(1)

Fondazione Policlinico Agostino Gemelli IRCCS

Roma, Italy

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NCT06355700


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