Creating organoids from colorectal tumors and liver metastases
Pilot Feasibility Study for the Development of Organoids From Primary Colorectal Tumors and Synchronous Liver Metastases
This study is trying to create mini versions of colorectal tumors and their liver spread to see how certain genes work and find new ways to treat cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Rome) |
| Trial ID | NCT06787625 on ClinicalTrials.gov |
What this trial studies
This pilot feasibility study focuses on developing organoids from primary colorectal tumors and their synchronous liver metastases. The organoids will be utilized to investigate the function of genes influenced by the NF-Y/p53 complex through gene overexpression and silencing. Functional assays will be conducted to assess proliferation, invasion, and motility, as well as interactions with patient-derived immune cells. The goal is to identify new therapeutic pathways for targeted therapy and immunotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a histological diagnosis of colorectal cancer that has metastasized to the liver and are eligible for surgical intervention.
Not a fit: Patients who do not have colorectal cancer or liver metastases, or those who are not candidates for surgery, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the discovery of new treatment targets for colorectal cancer and its metastases.
How similar studies have performed: While organoid technology is gaining traction, this specific approach targeting the NF-Y/p53 complex in colorectal cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients \> 18 years * Histological and cytological diagnosis of colorectal cancer neoplasia that has developed a liver metastasis * Patients who are candidates for surgery for colorectal cancer with liver metastasis * Signing of the relevant informed consent form. Exclusion Criteria: * All exclusion criteria adopted in surgical protocols will be applied to the study
Where this trial is running
Rome
- "Regina Elena" National Cancer Institute — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Giulia Piaggio, Biologist — IRCCS National Cancer Institute
- Study coordinator: Giulia Piaggio, Biologist
- Email: gialia.piaggio@ifo.it
- Phone: +39 0652662458
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.