Endometrial Cancer
Conditions
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.
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.
Interventions
GENETICGeneration 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.
Sponsors
Azienda Ospedaliera Universitaria Integrata Verona
Regina Elena Cancer Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of organoid generation | 42 months | 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. |
Countries
Italy
Contacts
Primary ContactGiovanni Blandino, Medical Doctor
Outcome results
None listed