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Trial Title:
Hepatocellular Carcinoma Liver Organoids
NCT ID:
NCT06355700
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Liver biopsy
Description:
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.
Arm group label:
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
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione Policlinico Agostino Gemelli IRCCS
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Francesca Ponziani, MD
Phone:
+390630156018
Email:
comitato.etico@policlinicogemelli.it
Start date:
June 15, 2023
Completion date:
March 2025
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06355700
