Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2025-03-23
2028-09-23
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Endometrial cavity infections (pyometra);
* Synchronous tumors;
* Neoadjuvant treatments;
* Previous radiation treatments to the pelvic region.
18 Years
FEMALE
No
Sponsors
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Azienda Ospedaliera Universitaria Integrata Verona
OTHER
Regina Elena Cancer Institute
OTHER
Responsible Party
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Locations
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IRCCS National Cancer Institute "Regina Elena"
Roma, Roma, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RS316/IRE/25
Identifier Type: -
Identifier Source: org_study_id
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