Using organoid models to study liver cancer
Organoid Models of Hepatocellular Carcinoma to Test Treatment Efficacy, Exploring Correlations With Tumor Microenvironment and Gut-liver-tumor Axis.
This study is trying to create mini-livers from patients' liver tissue to see how liver cancer behaves and how well different treatments work for people with the disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT06929845 on ClinicalTrials.gov |
What this trial studies
This study aims to develop patient-derived organoids (PDOs) from liver tissue to closely mimic the tumor microenvironment of hepatocellular carcinoma (HCC). The PDOs will be used to evaluate genomic and transcriptomic changes and their correlation with patient prognosis. Additionally, the study will test the efficacy of systemic therapies on these organoids, integrating patient-derived gut microbiota and immune cells to understand therapeutic responses. Advanced technologies such as next-generation sequencing and drug screening will be employed to enhance the understanding of treatment efficacy in HCC patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a suspected or confirmed diagnosis of hepatocellular carcinoma who are eligible for surgical resection.
Not a fit: Patients under 18 years old or those with contraindications to liver biopsy or surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment strategies for patients with hepatocellular carcinoma.
How similar studies have performed: Other studies utilizing organoid models for cancer research have shown promising results, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Capacity to express informed consent; * Age ≥18 years; * Suspected radiological diagnosis of HCC or diagnosis of HCC with indications for surgical resection. Exclusion Criteria: * Age \< 18 years; * Contraindications to liver biopsy (ascites, platelets\<50,000, INR\>1.7); * Contraindications to HCC resection surgery; * Active viral infection; * Refusal to sign informed consent to participate in the study.
Where this trial is running
Roma
- Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD, Largo A. Gemelli, 8 — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Francesca Romana Ponziani, PI — Fondazione Policlinico A. Gemelli IRCCS, Rome, Largo A. Gemelli, 8
- Study coordinator: Francesca Romana Ponziani, PI
- Email: francescaromana.ponziani@policlinicogemelli.it
- Phone: 3471227242
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.