Creating organoids from endometrial cancer tissue
Official title: Feasibility Study of the Generation of Endometrial Carcinoma Organoids From Tumor Samples Transferred From Extramural Facilities
Run by Regina Elena Cancer Institute · NCT07258186 · Data updated 2026-11-12
We will try to grow miniature tumor models (organoids) from surgical tissue of adults with endometrial cancer to see if transport and handling affect whether they can be grown.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 20 (estimated) |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Drugs / interventions | radiation, immunotherapy |
| Locations | 1 site (Roma, Roma) |
| Status | Recruiting |
| Started | March 23, 2025 |
| Main results expected | September 23, 2028 |
| Study ends | September 23, 2028 |
| Registry record updated | December 2, 2025 |
| Trial ID | NCT07258186 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (over 18) with histologically confirmed endometrioid endometrial cancer at any FIGO stage who are candidates for surgery or hysterectomy and can give informed consent.
✕Probably not a fit
Patients not undergoing surgery, those with non-endometrioid histology, or those excluded for active endometrial infection, uncontrolled comorbidities, synchronous tumors, neoadjuvant therapy, or prior pelvic radiation are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective pilot collects fresh tumor and nearby (peritumor) tissue at surgery, plus a preoperative blood sample, then freezes and ships samples to the IRE Translational Oncology Research Unit for processing. Tissue will be used to generate organoids and to perform genomic profiling (RNAseq and whole-exome sequencing), while blood will yield serum and PBMCs for storage and coculture experiments. The project specifically examines how transport and handling from collaborating centers affect tissue viability and organoid success. Clinical care and treatment decisions are not changed by participation; the work is exploratory to establish feasibility.
Why it matters
Potential benefit: If successful, the work could provide patient-specific tumor models that help test therapies and improve understanding of each tumor's biology.
How similar studies have gone: Organoid-generation methods have been reported with moderate success for endometrial and other gynecologic cancers, but yields and the effects of transport conditions remain variable and not fully standardized.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Comorbidities not controlled with adequate medical therapy; * Endometrial cavity infections (pyometra); * Synchronous tumors; * Neoadjuvant treatments; * Previous radiation treatments to the pelvic region.
Where it's running
-
IRCCS National Cancer Institute "Regina Elena"
Roma, Roma, Italy Recruiting
Study contacts
- Study coordinator: Giovanni Blandino, Medical Doctor
- Email: giovanni.blandino@ifo.it
- Phone: +39 0652662911
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.