Development of Organoids From Primary Colorectal Tumors and Synchronous Liver Metastases

Pilot Feasibility Study for the Development of Organoids From Primary Colorectal Tumors and Synchronous Liver Metastases

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06787625

Enrollment

Registered

2025-01-22

Start date

2024-05-25

Completion date

2028-05-25

Last updated

2025-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colo-rectal Cancer

Keywords

colororectal cancer, organoids

Brief summary

Pilot feasibility study for the development of organoids from primary colorectal tumors and synchronous liver metastases, to prepare organoids from primary colorectal tumors and synchronous liver metastases. The organoids will allow us to study the function of genes targeted by the activity of the NF-Y/p53 complex.

Detailed description

Organoids will allow us to study the function of genes that are targets of the NF-Y/p53 complex activity. In these organoids, we will perform overexpression and/or silencing of these genes and assays of proliferation, invasion and motility. We will also perform functional assays in cocultures of the organoids with PBMCs from the same patients. This could allow the discovery of new pathways that could be targeted by targeted therapy and/or immunotherapy. Organoid preparation will be performed from fresh colorectal cancer tissue and liver metastasis following enzymatic digestion. Organoid culture medium and specific organic matrix will be used

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Descriptive analyses	36 months	Given the pilot nature of the study, we will only perform descriptive analyses, overexpression or silencing experiments of target genes of the NF-Y/p53 complex activity. These experiments will indicate the impact on the viability of the organoid of target genes of the NF-Y/p53 complex activity. All the variables of interest will be summarized through absolute frequencies and percentages, if categorical or through medians and relative range, if continuous.

Countries

Italy

Contacts

Primary ContactGiulia Piaggio, Biologist

gialia.piaggio@ifo.it+39 0652662458

Outcome results