Creating liver organoids from patients with liver cancer
Hepatocellular Carcinoma Organoids to Explore Tumor Microenvironment and Test Treatment Efficacy - Hepatocellular Carcinoma Liver Organoids (HELIO)
This study is trying to create mini-livers from liver cancer patients' samples to see how they behave and respond to treatments in the lab.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT06355700 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to develop organoids from liver biopsy samples of individuals diagnosed with hepatocellular carcinoma (HCC). The research focuses on assessing the feasibility of integrating these organoids with host gut microbiota and peripheral blood mononuclear cells. Additionally, it seeks to analyze the molecular patterns within the organoid tumor microenvironment and evaluate the therapeutic responses of these organoids in vitro. By utilizing patient-derived samples, the study aims to enhance understanding of HCC biology and treatment responses.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed radiological diagnosis of hepatocellular carcinoma.
Not a fit: Patients under 18 years of age or those with contraindications for liver biopsy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved personalized treatment strategies for patients with hepatocellular carcinoma.
How similar studies have performed: While the approach of creating organoids from cancer tissues is gaining traction, this specific integration with gut microbiota and immune cells is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to express informed consent * Patients ≥ 18 years of age * Radiological diagnosis of hepatocellular carcinoma (HCC) Exclusion Criteria: * Patients \<18 years of age * Contraindications for liver biopsy: ascites, platelet count \<50.000, International Normalized Ratio (INR) \>1.7 * Active viral infection * Refusal to give informed consent for the study
Where this trial is running
Roma
- Fondazione Policlinico Agostino Gemelli IRCCS — Roma, Italy (Recruiting)
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.