Feasibility Study of the Generation of Endometrial Carcinoma Organoids From Tumor Samples Transferred From Extramural Facilities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of organoid generation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Comorbidities not controlled with adequate medical therapy;
- •Endometrial cavity infections (pyometra);
- •Synchronous tumors;
- •Neoadjuvant treatments;
- •Previous radiation treatments to the pelvic region.
结局指标
主要结局
Feasibility of organoid generation
时间窗: 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.
次要结局
未报告次要终点