Generation of Endometrial Carcinoma Organoids

Официальное название

Feasibility Study of the Generation of Endometrial Carcinoma Organoids From Tumor Samples Transferred From Extramural Facilities

Обзор

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.

Подробное описание

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.

Вмешательства

• Генная терапия 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.

Первичные конечные точки

• Feasibility of organoid generation [Срок оценки: 42 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• IRCCS National Cancer Institute "Regina Elena" — Roma

Идентификаторы

NCT: NCT07258186 · RS316/IRE/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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