Generation of Organotypic Liver Cultures for the Identification of Biomarkers for the Prevention and Treatment of Liver Fibrosis

NCT06252272 | Recruiting

• 1 other identifier: RS1822/23
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Low-level, interventional, biological and non-pharmacological study prospective intervention for the preparation of organotypic human liver slice cultures Liver Slice Culture (hLSC) applying the protocol described by Jiang and collaborators.

Conditions

Hepatic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Molecular characterization of liver fibrosis

  Creation of organotypic cultures of liverderived from liver biopsies taken from patients undergoing abdominal surgery for primary or secondary liver tumors for the molecular characterization of liver fibrosis.Patients will undergo abdominal surgery (as per clinical practice), during which a biopsy will be performed in an area of the liver macroscopically free from parenchymal alterations, approximately 20/25 slices will be obtained from each sample. The hLSCs will come used to study the hepatic microenvironment in the presence or absence of pro-fibrinogenetic stimuli e of anti-fibrotics by time-lapse analysis and confocal immunofluorescence microscopy multiple and through single cell sequencing.

  24 months

Secondary Outcomes (2)

• Study of the hepatic microenvironment

  24 months

• Compare the sequencing data

  24 months

Study Arms (1)

Biopsy sample in an area of liver macroscopically free from parenchymal alterations

OTHER

Patients undergoing abdominal surgery for primary or secondary liver tumors (liver metastases from colorectal, pancreatic, or breast), from which we proceed to the preparation of organotypic cultures of liver (hLSC) derived from liver biopsies taken from patients undergoing abdominal surgery for primary or secondary liver tumors for the molecular characterization of liver fibrosis.

Diagnostic Test: Biopsy from patients undergoing surgery abdominal.

Interventions

Biopsy from patients undergoing surgery abdominal. DIAGNOSTIC_TEST

A small portion (about 10 mm in diameter) of liver tissue was collected macroscopically free from alterations of the parenchyma obtained in the open at the site surgery for primary or secondary liver tumors, for the preparation of cultures of organotypic liver slices.

Biopsy sample in an area of liver macroscopically free from parenchymal alterations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 18 years old;
• patients for whom it is indicated to undergo abdominal surgery for tumors primary or secondary liver diseases;
• patients who express informed consent to the study.

You may not qualify if:

• medical contraindication to performing a liver biopsy;
• liver cirrhosis;
• macroscopic signs of chronic liver disease;
• moderate or severe steatosis;
• cholestasis;
• hepatic necrosis.

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• Federico II University: collaborator

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Silvia Soddu, Doctor

  IRCCS "Regina Elena" National Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Soddu, Doctor

CONTACT

06 5266 2492; silvia.soddu@ifo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Biopsy sample in an area of liver macroscopically free from parenchymal alterations
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-pharmacological study of a biological nature, low level interventional prospective intervention for the preparation of cultures of organotypic liver slices (hLSC)

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 9, 2024
• Study Start: January 17, 2023
• Primary Completion: January 17, 2025
• Study Completion: January 17, 2025
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

IT (1)