Generation of Endometrial Carcinoma Organoids (organoids endo)

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.

Study Overview

• Status: Recruiting
• Conditions: Endometrial Cancer
• Intervention / Treatment: Genetic: Generation of organoids from endometrial tumor tissue collected during surgery, performed according to standard clinical practice

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Giovanni Blandino, Medical Doctor; Phone Number: +39 0652662911; Email: giovanni.blandino@ifo.it

Study Locations

• Italy
  • Roma
    • Roma, Roma, Italy, 00144
      • Recruiting
      • IRCCS National Cancer Institute "Regina Elena"
      • Contact: Giovanni Blandino, Medical Doctor; Phone Number: +39 0652662911; Email: giovanni.blandino@ifo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a histological diagnosis of endometrioid endometrial cancer at any stage of the disease.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Genetic: Generation of organoids from endometrial tumor tissue collected during surgery, performed according to standard clinical practice; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	42 months

Collaborators and Investigators

• Sponsor: Regina Elena Cancer Institute
• Collaborators: Azienda Ospedaliera Universitaria Integrata Verona

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2025
• Primary Completion (Estimated): September 23, 2028
• Study Completion (Estimated): September 23, 2028

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Neoplasms; Endometrial Neoplasms
• Other Study ID Numbers: RS316/IRE/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No