Development of a Preclinical 3D Vascularized and Perfused Tumoroid Model in Oncology and Urology Developed From Patient Tumors (Kidney, Bladder, and Prostate Cancers)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Constitute and validate a panel of vascularized and perfused 3D tumoroids for personalized medicine based on patient tumors for urological cancers, incorporating autologous immune cells.
研究概览
简要总结
This is a study :
- Single-center
- Prospective
- Translational
- Based on data and blood samples. In this context, the aim is to collect approximately 10 ml of blood from each patient included in the 3D tumoroid development project.
The main objective is to establish and validate a panel of vascularized and perfused 3D tumoroids for personalized medicine based on patient tumors for urological cancers, incorporating autologous immune cells.
Translated with DeepL.com (free version)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •Criteria common to all patients:
- •Male or female subject (≥18 years old);
- •Diagnosed with kidney cancer, prostate cancer, or bladder cancer;
- •whose tumor tissue and associated data are reused as part of the SphéroUro protocol (study outside the Jardé law, retrospective study on tumor tissue and associated data, from the biobank registered with the Ministry of Education and Research under reference No. DC 2016-2677);
- •affiliated with a social security health insurance scheme or beneficiary of such a scheme;
- •agreeing to participate in the 3DBlood study.
- •Specific criteria for patients with renal cell carcinoma (RCC):
- •Extended nephrectomy (EN) (larger tumor, closer to the sinus; therefore at greater risk of metastasis): with a cavo, cavectomy (neoplastic thrombus in the vena cava), or renal vein bud, or lymph node dissection, or with adrenalectomy (often for tumors, therefore possible metastases).
- •- Partial nephrectomy (PN): with tumors at stage T2 or T3a)
排除标准
- •Patient refusal to participate in the study;
- •Inability to provide the subject with informed consent (subject in an emergency situation, difficulties in understanding the subject, etc.);
- •Patient under legal protection, guardianship, or conservatorship;
- •Patient currently participating in a therapeutic clinical trial (i.e., gene therapy or other).
结局指标
主要结局
Constitute and validate a panel of vascularized and perfused 3D tumoroids for personalized medicine based on patient tumors for urological cancers, incorporating autologous immune cells.
时间窗: Day 1 after surgery
For the establishment of the models, it is necessary to have: sufficient cell viability after enzymatic dissociation of the tissues and a correspondence of patient/model 3D therapeutic responses. The patients' blood will be collected to isolate immune cells using a Ficoll gradient, to integrate them into the forming 3D structures, taking into account the proportion present in the primary tumor tissues of each patient, for the 3D structures developed from their tumor.
次要结局
未报告次要终点