Hepatocellular Carcinoma Liver Organoids (HELIO)

April 3, 2024 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hepatocellular Carcinoma
Participants undergo to a liver biopsy, a venous blood sampling and a fecal sample collecting
Procedure: Liver 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of hepatocellular carcinoma organoids integrated with host gut microbiota and peripheral blood mononuclear cells
Time Frame: within 12 months
Number of successfully created organoids from all hepatocellular carcinoma samples
within 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of hepatocellular carcinoma organoid transcriptome distribution within a reference set from The Cancer Genome Atlas
Time Frame: within 12 months
Comparison between organoids transcriptome and data from The Cancer Genome Atlas
within 12 months
Evaluation of the concordance of somatic genetic mutations between the organoid and the original tumor
Time Frame: within 12 months
DNA organoids and original tumor sample sequencing and comparison between the somatic genetic mutations found in both models
within 12 months
Correlation between gut microbiota community profiling and growth rate of hepatocellular carcinoma organoids
Time Frame: within 12 months
Definition of microbiota composition via DNA and RNA sequencing and correlation between specific bacteria abundance and successful organoids growth
within 12 months
Treatment response evaluation in vitro
Time Frame: 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.
Day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5476

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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