Generation of Lung Tumor Organoids From Patients Undergoing Diagnostic Bronchoscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Preparation of at least 10 tumor organoid cultures lung
研究概览
简要总结
Interventional (low intervention level), non-pharmacological, prospective, feasibility pilot study of the preparation of organoids starting from lung tumor tissue collected during biopsies performed via diagnostic bronchoscopy according to standard clinical practice.
详细描述
Interventional, non-pharmacological, prospective, feasibility pilot study of the preparation of organoids starting from lung tumor tissue collected during biopsies performed via diagnostic bronchoscopy according to standard clinical practice. This protocol is classified as "interventional" (low intervention level) since that, if possible, an additional quantity of lung tumor tissue will be collected compared to that normally obtained as standard clinical practice, during bronchoscopy, al in order to increase the probability of successful generation of organoids. Involves the prospective recruitment of patients undergoing diagnostic bronchoscopies for suspected lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •patients with suspected diagnosis of centrally located and accessible lung cancer endoscopically;
- •patients for whom it is indicated to undergo in-depth diagnostic testing through bronchoscopy for the purpose of determining the histotype of the lung neoplasm, according to clinical practice standard;
- •aged over 18;
- •patients who express informed consent to the study.
排除标准
- •medical contraindication to taking biopsy samples;
- •medical contraindication to carrying out endoscopic investigations;
- •patients with suspected lung cancer not accessible endoscopically;
- •patients with lung neoformation already subjected to diagnostic sampling;
- •contraindications to taking an additional quantity of tissue.
结局指标
主要结局
Preparation of at least 10 tumor organoid cultures lung
时间窗: 12 months
Preparation of at least 10 tumor organoid cultures lung derived from patients undergoing diagnostic bronchoscopy. This study will allow define the success rate in the generation of organoids from diagnostic bronchoscopies. Performing a diagnostic bronchoscopy (scheduled as per clinical practice).
次要结局
- Correspondence between the generated organoids and the tissue tumor of origin(12 months)