NCT06355700UnknownNot Applicable
Hepatocellular Carcinoma Organoids to Explore Tumor Microenvironment and Test Treatment Efficacy - Hepatocellular Carcinoma Liver Organoids (HELIO)
Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country10 target enrollmentStarted: June 15, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Success rate of hepatocellular carcinoma organoids integrated with host gut microbiota and peripheral blood mononuclear cells
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Hepatocellular Carcinoma
Experimental
Participants undergo to a liver biopsy, a venous blood sampling and a fecal sample collecting
Intervention: Liver biopsy (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Evaluation of the concordance of somatic genetic mutations between the organoid and the original tumor(within 12 months)
- Correlation between gut microbiota community profiling and growth rate of hepatocellular carcinoma organoids(within 12 months)
- Treatment response evaluation in vitro(Day 5)
- Analysis of hepatocellular carcinoma organoid transcriptome distribution within a reference set from The Cancer Genome Atlas(within 12 months)
Investigators
Study Sites (1)
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