Patient-derived Organoids of Lung Cancer to Test Drug Response
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Patient-derived organoid validation
研究概览
简要总结
This is a single center, single arm, open and exploratory clinical study, with 50 cases planned for a period of 3 years. The purpose of this study is to evaluate the consistency and accuracy of a Patient-Derived Organoid (PDO) Model of lung cancer to predict the clinical efficacy of anti-cancer drugs, in order to predict the best chemotherapy regimen for each given patient.
详细描述
The aim of the project is to use a combination of patient-derived organoid models:
- To amplify tumour tissue to obtain enough material for genomic and histological analysis
- to characterize the lung cancer sub-type
- To predict treatment (non)response.
The following points will be addressed:
- First, the investigators plan to establish and characterize formation of organoids from biopsies of patients with lung cancer: in spheroids, in the 3D cellular model OncoCilAirTM (OncoTheis), and on the chick chorioallantoic membrane (CAM). Patient-derived organoids from tumoural tissue (PDO) will be characterized and compared to the original tumour.
- Second, the investigators will test the chemoresponse (chemosensitivity and chemoresistance) of organoids to anti-cancer treatment.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven lung cancer
- •Written informed and signed consent
- •Accessible to biopsy and/or surgery sample of metastasis and/or primitive tumour
排除标准
- •Less than 18 years of age
- •Not able to give informed consent (language, intellectual capacities, etc.)
- •Not accessible to biopsy and/or surgery sample
- •Not enough lung tissue for a histological analysis or the remaining lung tissue is not enough to perform a routine pathological analysis.
结局指标
主要结局
Patient-derived organoid validation
时间窗: 5 years
Proportion of patient-derived organoids that are histologically and genetically identical to the source tumour
Patient-derived organoid establishment
时间窗: 3 years
Successful generation of lung cancer organoids (growth of lung tumoral cells). The rate of successful generation of lung cancer organoids could vary with the age of the patient, the histological and molecular subtype of lung cancer
次要结局
- Drug sensitivity(2019 - 2023)
- Prediction of the response to treatment by the patient-derived organoids(2020 - 2025)
研究者
Frederic TRIPONEZ
Professor
University Hospital, Geneva