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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-17

Study Completion Date

2025-01-17

Brief Summary

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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.

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Detailed Description

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Human liver slice culture hLSCs will be used from non-tumor liver tissue collected by biopsy from patients undergoing abdominal surgery, who have signed informed consent and agree to perform a liver biopsy for the specific research protocol.

The study is "low level interventional" when a small portion (approximately 10 mm in diameter) of liver tissue macroscopically free from parenchymal alterations obtained in the open at the site of surgery for primary or secondary liver tumors will be taken (hepatic metastases from colorectal, pancreatic or breast cancer). The goal is to create organotypic liver cultures (hLSC) derived from liver biopsies taken from patients undergoing abdominal surgery.

for primary or secondary liver tumors for the molecular characterization of liver fibrosis.

Use hLSC to study the liver microenvironment and molecular determinants involved in fibrosis through single cell sequencing; compare the sequencing data obtained with hLSC with that obtained via characterization of a GEMM whose generation is foreseen in the same project financed by the MoS.

To generate this GEMM, the pro-fibrotic Hipk2 gene was specifically deleted in the tissue liver (HIPK2-liver knock-out, HIPK2-LKO) and liver fibrosis will be induced through a high-fat, low-choline diet.

Conditions

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Hepatic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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

Study Groups

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

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.

Group Type OTHER

Biopsy from patients undergoing surgery abdominal.

Intervention Type 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.

Interventions

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Biopsy from patients undergoing surgery abdominal.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes