Development of a Neuronal Microscope

NCT06311396 | Completed

• 1 other identifier: REVEAL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatic Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Neuronal micRoscopy for cEll behaVioural Examination and mAnipuLation

EXPERIMENTAL

validate the ability of a neuronal microscope to decipher the biomechanism at the origin of liver cancer, especially addressing the problem of biological heterogeneity

Genetic: genetic model

Interventions

genetic model GENETIC

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

Neuronal micRoscopy for cEll behaVioural Examination and mAnipuLation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• positivity for chronic viral hepatitis (HCV-RNA and HBsAg).

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica

Milan, Milano, 20122, Italy

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Models, Genetic

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Models, Biological; Models, Theoretical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Luca Vittorio Carlo Valenti

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: January 1, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

IT (1)