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Trial Title:
Development of a Neuronal Microscope
NCT ID:
NCT06311396
Condition:
Hepatic Carcinoma
Conditions: Official terms:
Carcinoma, Hepatocellular
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Genetic
Intervention name:
genetic model
Description:
Create a complete molecular-level description of the heterogeneous population of cells
that are capable of giving rise to tumor transformation in the liver.
Arm group label:
Neuronal micRoscopy for cEll behaVioural Examination and mAnipuLation
Summary:
Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer and is a
leading cause of cancer-related death worldwide. The prognosis of HCC remains poor, with
a 5-year survival rate of 18%. Risk factors for HCC include viral infection, autoimmune
hepatitis, chronic alcohol use or metabolic fatty liver disease, obesity, and diabetes
mellitus.
Detailed description:
Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer and is a
leading cause of cancer-related death worldwide. The prognosis of HCC remains poor, with
a 5-year survival rate of 18%. Risk factors for HCC include viral infection, autoimmune
hepatitis, chronic alcohol use or metabolic fatty liver disease, obesity, and diabetes
mellitus. Furthermore, alterations and chronic inflammation of the microenvironment can
facilitate the transformation of normal liver stem cells into precancerous tumor stem
cells. All these underlying pathogenic stimuli can induce a spectrum of genetic and
epigenetic modifications, which are involved in the cell cycle, cell growth and
regulation of adhesion. Therefore, heterogeneity and tumor priming potential arise from a
combination of both endogenous and exogenous factors. However, current in vitro models,
based on conventional hepatoma and hepatocarcinoma cell lines, fail to recapitulate key
characteristics of tumor tissue such as three-dimensional tissue architecture, cellular
heterogeneity, and cell-cell interactions. Organoids, which are 3D cellular structures
generated from induced pluripotent stem cells and adult tissue-resident stem cells, have
recently been exploited to overcome the limitations of 2D cell culture systems, emerging
as powerful tools for studying human diseases. Therefore, organoid structures stably
preserve the genetic information of autologous tissue by mimicking the pathological state
of the tissue itself.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Patients aged >18 years:
- undergoing surgical cholecystectomy, liver resection for hepatocellular carcinoma
(both intra-tumoral and extra-tumoral tissues) or whole liver explants;
- who have given consent to participate in the study.
Exclusion Criteria:
• positivity for chronic viral hepatitis (HCV-RNA and HBsAg).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica
Address:
City:
Milan
Zip:
20122
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Luca Vittorio Carlo Valenti
Phone:
02 5503 6595
Phone ext:
56595
Email:
luca.valenti@policlinico.mi.it
Start date:
January 1, 2021
Completion date:
January 1, 2025
Lead sponsor:
Agency:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Agency class:
Other
Source:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06311396
