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RecruitingNCT06787625Updated Jan 22, 2025

Development of Organoids From Primary Colorectal Tumors and Synchronous Liver Metastases

An observational study in Colo-rectal Cancer, sponsored by Regina Elena Cancer Institute. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-22.

Sponsored by Regina Elena Cancer Institute · Observational

From the registry’s dates

  • Started May 2024; still recruiting 2 years 4 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Colo-rectal Cancer

Keywords

  • colororectal cancer
  • organoids
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 10 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Regina Elena Cancer Institute is the lead sponsor of 92 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with colorectal cancer and synchronous liver metastases who will undergo liver resection surgery

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

Exclusion Criteria:

  • All exclusion criteria adopted in surgical protocols will be applied to the study
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
10 participants (estimated)
Target follow-up
36 Months
Patient registry
Yes
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Descriptive analyses

    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.

    Time frame: 36 months

07

Study locations

1 of 1 sites recruiting
  • "Regina Elena" National Cancer Institute
    Rome, 00144, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06787625
Lead sponsor
Regina Elena Cancer Institute
Responsible party
Sponsor
First posted
Jan 22, 2025
Start date
May 25, 2024
Primary completion
Jan 25, 2028 (estimated)
Completion
May 25, 2028 (estimated)
Last update
Jan 22, 2025

Study contacts

Giulia Piaggio, Biologist
Contact
gialia.piaggio@ifo.it
+39 0652662458
Giulia Piaggio, Biologist
principal investigator · IRCCS National Cancer Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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