NCT04039672已完成不适用
Interest of Tumor Replicates in Avian Embryo to Model Therapeutic Effects of BRAF Inhibitors/MEK Inhibitors (BRAFi/MEKi) in BRAF Mutated Melanoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Grafted avian embryo development
研究概览
简要总结
This is an interventional mono-centric study in patients with BRAF mutated metastatic melanoma treated with BRAF/MEK inhibitors. The aim of the study is to test the grafting of patient tumoral cells in avian embryo and develop a predictive in vivo model for patient treatment response.
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 aged ≥ 18 years
- •Signed written informed consent
- •Patient with BRAF V600 mutated metastatic or unresectable melanoma histologically confirmed
- •BRAFi/MEKi treatment indication
- •Patient with skin tumor (excluded face and skinfold) available for biopsy
- •Measurable disease as defined by RECIST v1.1 criteria
- •Patient affiliated to or a beneficiary of a social security category
排除标准
- •Ocular melanoma
- •Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
- •Pregnant or nursing (lactating) women
- •Patients protected by law
结局指标
主要结局
Grafted avian embryo development
时间窗: 2 days post graft
Number of grafted embryo which develop tumor measurable by 3D microscopy
Grafted avian embryo viability
时间窗: 2 days post graft
Survival rate of grafted embryo
次要结局
- BRAFi/MEKi maximum toxic effect dose in avian embryo(3 months post treatment administration)
- BRAFi maximum toxic effect dose in avian embryon(3 months post treatment administration)
- Patient treatment response(3 months post inclusion)
- Embryo treatment response (tumor)(2 days post graft)
- Embryo treatment response (metastasis)(2 days post graft)
- MEKi maximum toxic effect dose in avian embryo(3 months post treatment administration)
- BRAFi maximum toxic effect dose in avian embryo(3 months post treatment administration)
研究者
研究点 (2)
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