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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06311396
Other study ID # REVEAL
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date January 1, 2025

Study information

Verified date March 2024
Source Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact Luca Vittorio Carlo Valenti
Phone 02 5503 6595
Email luca.valenti@policlinico.mi.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date January 1, 2025
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
genetic model
Create a complete molecular-level description of the heterogeneous population of cells that are capable of giving rise to tumor transformation in the liver.

Locations

Country Name City State
Italy Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica Milan Milano

Sponsors (1)

Lead Sponsor Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Isolation of epithelial cells Isolation of epithelial cells to ultimately generate models of major hepatocellular carcinoma cell populations in three-dimensional culture environment, called liver organoids, and molecular characterization of the generated models. January 2021 - January 2025
Primary Omics studies and functional morphological studies Knowledge of the behavioral and morphological differences between physiological and tumor hepatocytes;
Knowledge of the molecular mechanisms underlying cellular level observations exploiting "omics" scale assessments and CRISPR-Cas9 genetic engineering
January 2021 - January 2025
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