Colo-rectal CancerNCT06787625
Development of Organoids From Primary Colorectal Tumors and Synchronous Liver Metastases
An observational study of Colo-rectal Cancer, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 25 May 2024to 25 May 2028
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with colorectal cancer and synchronous liver metastases who will undergo liver resection surgery
Who may be able to join
- 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.
Who cannot join
- All exclusion criteria adopted in surgical protocols will be applied to the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
"Regina Elena" National Cancer Institute
Rome, 00144
Giulia Piaggio, Biologist, +39 0652662458, giulia.piaggio@ifo.it
About this study
Official title: Pilot Feasibility Study for the 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.
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
- Conditions
- Colo-rectal Cancer
- Keywords
- colororectal cancer, organoids
- Medical subject headings
- Colonic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start25 May 2024
- Primary completion25 Jan 2028 (estimated)
- Study completion25 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giulia Piaggio, Biologist, Principal investigator, IRCCS National Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787625
- Sponsor's protocol ID
- RS87/IRE/24
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Study for the Development of Organoids From Primary Colorectal Tumors and Synchronous Liver Metastases
- ClinicalTrials.gov ID
- NCT06787625
- Acronym / sponsor ID
- RS87/IRE/24
- Conditions
- Colo-rectal Cancer
- Keywords
- colororectal cancer, organoids
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- 25 May 2024 (actual)
- Primary completion
- 25 Jan 2028 (estimated)
- Study completion
- 25 May 2028 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 36 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colorectal cancer and synchronous liver metastases who will undergo liver resection surgery
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- All exclusion criteria adopted in surgical protocols will be applied to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giulia Piaggio, Biologist principal investigator
IRCCS National Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colo-rectal Cancer, run by Regina Elena Cancer Institute at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giulia Piaggio, Biologist (+39 0652662458, gialia.piaggio@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive analyses (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.