Generation of Endometrial Carcinoma Organoids (organoids endo)

Regina Elena Cancer Institute

Status: Enrolling

Conditions: Endometrial Cancer

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

Study type: Observational

Funder types: Other

Identifiers

NCT07258186

RS316/IRE/25

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

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

Description:

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.

Treatment:

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