Generation of Endometrial Carcinoma Organoids

NCT07258186 | Recruiting

• 1 other identifier: RS316/IRE/25
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Generation of organoids from endometrial tumor tissue collected during surgery, performed according to standard clinical practice GENETIC

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.

Patients with endometrial cancer of the endometrioid histology at any stage of the disease.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Comorbidities not controlled with adequate medical therapy;
• Endometrial cavity infections (pyometra);
• Synchronous tumors;
• Neoadjuvant treatments;
• Previous radiation treatments to the pelvic region.

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• Azienda Ospedaliera Universitaria Integrata Verona: collaborator

Study Sites (1)

IRCCS National Cancer Institute "Regina Elena"

Roma, Roma, 00144, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fresh tumor and peri-tumor tissues Blood (Serum and PBMC)

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Giovanni Blandino, Medical Doctor

CONTACT

+39 0652662911; giovanni.blandino@ifo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 2, 2025
• Study Start: March 23, 2025
• Primary Completion (Estimated): September 23, 2028
• Study Completion (Estimated): September 23, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

IT (1)