Endometrial Cancerorganoids endoNCT07258186
Generation of Endometrial Carcinoma Organoids
An observational study of Endometrial Cancer, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
A prospective pilot genetic study to evaluate the feasibility of generating organoids from endometrial tumor tissue collected during surgery, performed according to standard clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Generation of organoids from endometrial tumor tissue collected during surgery, performed according to standard clinical practice
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 23 Mar 2025to 23 Sep 2028
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a histological diagnosis of endometrioid endometrial cancer at any stage of the disease.
Who may be able to join
- Age >18 years;
- Patients with a histological diagnosis of: endometrial cancer, endometrioid histology, any stage of disease (FIGO I-IV), recurrence/metastasis from endometrial endometrioid cancer, and candidates for surgery and/or hysterectomy;
- Written informed consent (study participation and data processing) must be obtained in person and/or through a legal representative/guardian/support administrator/witness, before any study-specific procedure is performed.
Who cannot join
- Comorbidities not controlled with adequate medical therapy;
- Endometrial cavity infections (pyometra);
- Synchronous tumors;
- Neoadjuvant treatments;
- Previous radiation treatments to the pelvic region.
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
IRCCS National Cancer Institute "Regina Elena"
Roma, Roma, 00144
Giovanni Blandino, Medical Doctor, +39 0652662911, giovanni.blandino@ifo.it
About this study
Official title: Feasibility Study of the Generation of Endometrial Carcinoma Organoids From Tumor Samples Transferred From Extramural Facilities
A prospective pilot genetic study to evaluate the feasibility of generating organoids from endometrial tumor tissue collected during surgery, performed according to standard clinical practice. Samples will be collected from collaborating extramural facilities, with the aim of analyzing the impact of transport on tissue viability and the success of organoid culture. This study is for exploratory purposes only, without altering the diagnostic and therapeutic pathways of the participants.
Read the detailed description
The prospective study involves the collection and freezing of biological samples at the IRE Translational Oncology Research Unit. Collecting and using:
- Fresh tissue: tumor and peritumor tissue from the same patient, obtained surgically at participating centers, will be collected under the supervision of a dedicated pathologist, sent to the IRE Translational Oncology Research Unit, and frozen. The collected tissue will be processed and used to perform gene expression profiling using RNAseq and WES and to generate organoids.
- Blood (Serum and PBMCs) - A blood sample (EmoT0) will also be collected for each patient before surgery. This sample will be used to prepare serum for aliquoting/freezing, and peripheral blood mononuclear cells (PBMCs). These will also be sent, frozen, and stored at the IRE Translational Oncology Research Unit. These will be used to evaluate the organoids' response to immunotherapy treatments through coculture experiments.
Only biological material whose availability and suitability are guaranteed will be used to archive appropriate material as required by law. It will then be sent to the research laboratories of the IRE Translational Oncology Research Unit and will be used for genomic analysis and the generation of organoids.
- Conditions
- Endometrial Cancer
- Being tested
- Generation of organoids from endometrial tumor tissue collected during surgery, performed according to standard clinical practice
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generation of organoids from endometrial tumor tissue collected during surgery, performed according to standard clinical practiceGenetic
Creation of endometrial carcinoma organoids from tumor tissue from extramural structures, verifying the feasibility of organoid generation. Evaluate the impact of sample transport and storage conditions on the success of the process, considering the challenges associated with preserving tissue integrity.
| Study group | Role | What they receive |
|---|---|---|
| Patients with endometrial cancer of the endometrioid histology at any stage of the disease. | Patients aged 18 years and older with a histological diagnosis of endometrial cancer of the endometrioid histology at any stage of disease (FIGO I-IV), recurrence/metastasis from endometrial endometrioid cancer, who are candidates for surgery or hysterectomy and who will undergo surgery after signing an informed consent form, will be prospectively recruited. Receives: Genetic: Generation of organoids from endometrial tumor tissue collected during surgery, performed according to standard clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of organoid generation
The feasibility of generating endometrial carcinoma organoids from tumor tissue will be assessed by analyzing the success rate in organoid generation, expressed as a percentage.
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start23 Mar 2025
- Primary completion23 Sep 2028 (estimated)
- Study completion23 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258186
- Sponsor's protocol ID
- RS316/IRE/25
- Acronym
- organoids endo
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Generation of Endometrial Carcinoma Organoids From Tumor Samples Transferred From Extramural Facilities
- ClinicalTrials.gov ID
- NCT07258186
- Acronym / sponsor ID
- organoids endo / RS316/IRE/25
- Conditions
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona
- Study start
- 23 Mar 2025 (actual)
- Primary completion
- 23 Sep 2028 (estimated)
- Study completion
- 23 Sep 2028 (estimated)
- First posted
- 2 Dec 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.
A prospective pilot genetic study to evaluate the feasibility of generating organoids from endometrial tumor tissue collected during surgery, performed according to standard clinical practice. Samples will be collected from collaborating extramural facilities, with the aim of analyzing the impact of transport on tissue viability and the success of organoid culture. This study is for exploratory purposes only, without altering the diagnostic and therapeutic pathways of the participants.
Detailed description
The prospective study involves the collection and freezing of biological samples at the IRE Translational Oncology Research Unit. Collecting and using:
- Fresh tissue: tumor and peritumor tissue from the same patient, obtained surgically at participating centers, will be collected under the supervision of a dedicated pathologist, sent to the IRE Translational Oncology Research Unit, and frozen. The collected tissue will be processed and used to perform gene expression profiling using RNAseq and WES and to generate organoids.
- Blood (Serum and PBMCs) - A blood sample (EmoT0) will also be collected for each patient before surgery. This sample will be used to prepare serum for aliquoting/freezing, and peripheral blood mononuclear cells (PBMCs). These will also be sent, frozen, and stored at the IRE Translational Oncology Research Unit. These will be used to evaluate the organoids' response to immunotherapy treatments through coculture experiments.
Only biological material whose availability and suitability are guaranteed will be used to archive appropriate material as required by law. It will then be sent to the research laboratories of the IRE Translational Oncology Research Unit and will be used for genomic analysis and the generation of organoids.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with endometrial cancer of the endometrioid histology at any stage of the disease. | – | Genetic: Generation of organoids from endometrial tumor tissue collected during surgery, performed according to standard clinical practicePatients aged 18 years and older with a histological diagnosis of endometrial cancer of the endometrioid histology at any stage of disease (FIGO I-IV), recurrence/metastasis from endometrial endometrioid cancer, who are candidates for surgery or hysterectomy and who will undergo surgery after signing an informed consent form, will be prospectively recruited. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a histological diagnosis of endometrioid endometrial cancer at any stage of the disease.
Key inclusion criteria (3 listed)
- Age >18 years;
- Patients with a histological diagnosis of: endometrial cancer, endometrioid histology, any stage of disease (FIGO I-IV), recurrence/metastasis from endometrial endometrioid cancer, and candidates for surgery and/or hysterectomy;
- Written informed consent (study participation and data processing) must be obtained in person and/or through a legal representative/guardian/support administrator/witness, before any study-specific procedure is performed.
Key exclusion criteria (5 listed)
- Comorbidities not controlled with adequate medical therapy;
- Endometrial cavity infections (pyometra);
- Synchronous tumors;
- Neoadjuvant treatments;
- Previous radiation treatments to the pelvic region.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Generation of organoids from endometrial tumor tissue collected during surgery, performed according to standard clinical practiceCreation of endometrial carcinoma organoids from tumor tissue from extramural structures, verifying the feasibility of organoid generation. Evaluate the impact of sample transport and storage conditions on the success of the process, considering the challenges associated with preserving tissue integrity. | Genetic | Patients with endometrial cancer of the endometrioid histology at any stage of the disease. |
Primary outcome
Feasibility of organoid generation
Time frame: 42 months
The feasibility of generating endometrial carcinoma organoids from tumor tissue will be assessed by analyzing the success rate in organoid generation, expressed as a percentage.
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 2 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Endometrial 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 3 inclusion and 5 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 2 Dec 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 Giovanni Blandino, Medical Doctor (+39 0652662911, giovanni.blandino@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of organoid generation (time frame: 42 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 2 Dec 2025.