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

Hepatocellular Carcinoma

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

Plain Language Summary

Simplified for easier understanding

This study uses liver biopsy samples to grow "organoids" — tiny lab-grown models of liver cancer tumors — to study how hepatocellular carcinoma (HCC, the most common type of liver cancer) behaves and responds to different treatments. This is a laboratory-focused study that uses your tissue to advance research. **You may be eligible if...** - You are 18 or older - You have been diagnosed with liver cancer (hepatocellular carcinoma) based on imaging - You are able to give informed consent **You may NOT be eligible if...** - You are under 18 years old - You have conditions that make a liver biopsy unsafe: fluid in the abdomen (ascites), a platelet count below 50,000, or a high INR (a blood clotting measure) - You have an active viral infection - You refuse to give consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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