Hepatic FibrosisNCT06252272
Generation of Organotypic Liver Cultures for the Identification of Biomarkers for the Prevention and Treatment of Liver Fibrosis
A study testing Biopsy from patients undergoing surgery abdominal. in people with Hepatic Fibrosis, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatic Fibrosis
- What is being tested?
- Biopsy from patients undergoing surgery abdominal.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jan 2023to 17 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- medical contraindication to performing a liver biopsy;
- liver cirrhosis;
- macroscopic signs of chronic liver disease;
- moderate or severe steatosis;
- cholestasis;
- hepatic necrosis.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
"Regina Elena" National Cancer Institute
Rome, 00144
Silvia Soddu, Doctor, 06 5266 2492, silvia.soddu@ifo.it
About this study
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.
Read the detailed description
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
- Hepatic Fibrosis
- Being tested
- Biopsy from patients undergoing surgery abdominal.
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Biopsy from patients undergoing surgery abdominal. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (2)
Study of the hepatic microenvironment
Use hLSCs to study the liver microenvironment and the molecular determinants involved in it fibrosis through single cell sequencing (single-cell RNA sequencing);
Measured: 24 months
Compare the sequencing data
Compare the sequencing data obtained with hLSCs with those obtained through the characterization of a GEMM. A biopsy will be performed after abdominal surgery (as per clinical practice), in an area of the liver macroscopically free from parenchymal alterations.
hLSCs will be analyzed over the following week for viability and fibrosis induction using fibrosis-specific stains for time-lapse dynamic imaging (IncuCyte), i.e. picrosirius red, Masson's trichrome, and quantitative RT-PCR and multiplex immunofluorescence
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start17 Jan 2023
- Primary completion17 Jan 2025 (estimated)
- Study completion17 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-pharmacological study of a biological nature, low level interventional prospective intervention for the preparation of cultures of organotypic liver slices (hLSC)
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University
- Responsible party
- Sponsor
- Investigators
- Silvia Soddu, Doctor, Principal investigator, IRCCS "Regina Elena" National Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252272
- Sponsor's protocol ID
- RS1822/23
- Status last verified
- Feb 2024
- First submitted
- 17 Jan 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation of Organotypic Liver Cultures for the Identification of Biomarkers for the Prevention and Treatment of Liver Fibrosis
- ClinicalTrials.gov ID
- NCT06252272
- Acronym / sponsor ID
- RS1822/23
- Conditions
- Hepatic Fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- Federico II University
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 17 Jan 2025 (estimated)
- Study completion
- 17 Jan 2025 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-pharmacological study of a biological nature, low level interventional prospective intervention for the preparation of cultures of organotypic liver slices (hLSC)
| Arm | Type | Receives |
|---|---|---|
| Biopsy sample in an area of liver macroscopically free from parenchymal alterations | Other | Diagnostic Test: Biopsy from patients undergoing surgery abdominal.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- medical contraindication to performing a liver biopsy;
- liver cirrhosis;
- macroscopic signs of chronic liver disease;
- moderate or severe steatosis;
- cholestasis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Biopsy sample in an area of liver macroscopically free from parenchymal alterations |
Primary outcome
Molecular characterization of liver fibrosis
Time frame: 24 months
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.
2 secondary outcomes
Study of the hepatic microenvironment
Time frame: 24 months
Compare the sequencing data
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Soddu, Doctor principal investigator
IRCCS "Regina Elena" National Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy from patients undergoing surgery abdominal. in people with Hepatic Fibrosis, run by Regina Elena Cancer Institute at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Soddu, Doctor (06 5266 2492, silvia.soddu@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular characterization of liver fibrosis (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.