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, 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.

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Key information

Conditions

Colo-rectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

Location status: Recruiting

Location contact

Giulia Piaggio, Biologist

CONTACT

[email protected]

+39 0652662458

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Descriptive analyses

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Giulia Piaggio, Biologist

CONTACT

[email protected]

+39 0652662458

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2028
Study completion: 2028
First posted: Jan 22, 2025
Registry last updated: Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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