Creating organoids from endometrial cancer tissue
Feasibility Study of the Generation of Endometrial Carcinoma Organoids From Tumor Samples Transferred From Extramural Facilities
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 |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Drugs / interventions | radiation, immunotherapy |
| Locations | 1 site (Roma, Roma) |
| Trial ID | NCT07258186 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Roma, Roma
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.