Actively Recruiting
Pilot Feasibility Study for the Development of Organoids From Primary Colorectal Tumors and Synchronous Liver Metastases
Led by Regina Elena Cancer Institute · Updated on 2025-01-22
10
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a pilot feasibility study to develop organoids from primary colorectal tumors and synchronous liver metastases. These organoids will help study the function of genes targeted by the NF-Y/p53 complex, which plays a role in cancer cell behavior. The goal is to understand gene functions related to proliferation, invasion, and motility in colorectal cancer and its liver metastases. The organoids will be created from fresh colorectal cancer tissue and liver metastases using enzymatic digestion. They will be grown in a specialized culture medium with an organic matrix. Researchers will manipulate gene expression in these organoids and perform functional assays, including cocultures with immune cells from the same patients, to explore new pathways for potential targeted therapies and immunotherapy. Participants will provide tissue samples during surgery for colorectal cancer with liver metastases. The study will analyze these samples over 36 months using descriptive methods. The research includes gene function assays, immune cell interactions, and tracking the organoid behavior. Participants must provide informed consent and meet surgery-related criteria. This observational study aims to deepen understanding of colorectal cancer biology.
CONDITIONS
Brief Title
Development of Organoids From Primary Colorectal Tumors and Synchronous Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years
- Histological and cytological diagnosis of colorectal cancer with liver metastasis
- Candidates for surgery for colorectal cancer and liver metastasis
- Signing of informed consent form
You will not qualify if you...
- All exclusion criteria adopted in surgical protocols will be applied to the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Surgery day and immediate recovery period
Participants undergo surgery for colorectal cancer and liver metastasis with collection of tissue samples for organoid development.
1 surgery visit and immediate post-operative care
Duration - During surgery and initial recovery
Fresh colorectal cancer tissue and liver metastasis samples are collected for organoid preparation and functional assays.
Sample collection during surgery visit
Duration - Up to 36 months
Participants are followed for up to 36 months for descriptive analyses related to organoid development and study outcomes.
Trial Site Locations
Total: 1 location
1
"Regina Elena" National Cancer Institute
Rome, Italy, 00144
Actively Recruiting
Research Team
G
Giulia Piaggio, Biologist
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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