NCT06787625

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
22mo left

Started May 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
May 2024May 2028

Study Start

First participant enrolled

May 25, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2028

Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

3.7 years

First QC Date

January 16, 2025

Last Update Submit

January 16, 2025

Conditions

Colo-rectal Cancer

Keywords

colororectal cancerorganoids

Outcome Measures

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.

    36 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

colorectal tumor tissue samples, liver metastases tissue samples, whole blood

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Giulia Piaggio, Biologist

    IRCCS National Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giulia Piaggio, Biologist

CONTACT

+39 0652662458gialia.piaggio@ifo.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
36 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2025

First Posted

January 22, 2025

Study Start

May 25, 2024

Primary Completion (Estimated)

January 25, 2028

Study Completion (Estimated)

May 25, 2028

Last Updated

January 22, 2025

Record last verified: 2025-01

Locations

IT(1)