Creating liver cultures to find biomarkers for liver fibrosis treatment
Generation of Organotypic Liver Cultures for the Identification of Biomarkers for the Prevention and Treatment of Liver Fibrosis
This study is trying to create lab-grown liver samples to see if they can help find new ways to treat liver fibrosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06252272 on ClinicalTrials.gov |
What this trial studies
This study focuses on generating organotypic human liver slice cultures (hLSC) from non-tumor liver tissue obtained via biopsy during abdominal surgeries. The aim is to investigate the liver microenvironment and molecular factors involved in hepatic fibrosis using advanced techniques like single-cell sequencing. By comparing the data from these cultures with genetically engineered mouse models, the study seeks to enhance understanding of liver fibrosis and identify potential biomarkers for prevention and treatment.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 who are scheduled for abdominal surgery due to primary or secondary liver tumors and can provide informed consent.
Not a fit: Patients with liver cirrhosis, chronic liver disease, or other significant liver conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved strategies for preventing and treating liver fibrosis in patients.
How similar studies have performed: While the approach of using organotypic liver cultures is established, the specific application for identifying biomarkers in liver fibrosis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Rome
- "Regina Elena" National Cancer Institute — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Silvia Soddu, Doctor — IRCCS "Regina Elena" National Cancer Institute
- Study coordinator: Silvia Soddu, Doctor
- Email: silvia.soddu@ifo.it
- Phone: 06 5266 2492
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.