Development of a Platform of Patient Derived Xenografts (PDX) and 2D/3D Cell Cultures of Soft Tissue Sarcomas (STS): Protocol to Obtain Tumour Material From Patients With STS.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The take-rate of fresh human PDX tumour material in nude mice.
研究概览
简要总结
Outside the setting of well-designed prospective clinical studies, the current standard preoperative RT should be a conventionally 1.8-2 Gy fractionated regimen to a total dose of 50 Gy in 5-6 weeks. However, given the vast diversity of sarcoma subtypes, it is also unlikely to assume a uniform therapeutic management to be optimal for all sarcomas alike. Other than 2 Gy fraction sizes and/or 50 Gy total dose series have been investigated in the past and should be further exploited in the future, but the practical implementation in humans is hampered by the rarity of the disease.
The current systemic treatment of sarcomas consists of both the older cytotoxic chemotherapies and the newer targeted therapies like tyrosine kinase inhibitors. But it is hard to predict which patients will respond to which specific systemic treatment. This leads to worse prognoses and unnecessary toxicity for sarcoma patients. Despite the fact that the number of sarcoma patients in current studies is too small with a mix of different subtypes, some subtypes show a better response than other subtypes. This platform may form the basis for preclinical translational investigations with radiotherapy and various systemic treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Histologically confirmed diagnosed (non-) metastatic intermediate to high grade STS
- •Local recurrences are allowed
- •Age ≥ 18 years
- •Able and willing to undergo tumour biopsies or tumour sampling during surgery
- •Localization of sarcoma enables safe biopsy or surgery
- •Written informed consent
排除标准
- •Known coagulation disorder and/or anticoagulant medication in as far it might interfere with a safe biopsy procedure (to the discretion of the treating physician and attending radiologist)
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the study
研究组 & 干预措施
single arm
single tumor biopsy
干预措施: tumor biopsy (Other)
结局指标
主要结局
The take-rate of fresh human PDX tumour material in nude mice.
时间窗: 4 months
take rate
A platform of 2D/3D cell cultures (organoids) of Soft Tissue Sarcomas.
时间窗: 6 weeks
take rate
A consistent system for further anti-sarcoma therapy (both RT and chemotherapy experiments)
时间窗: 2 years after start of study
take rate
A model for translational research
时间窗: 2 years after start of study
take rate
A platform of Patient Derived Xenografts (PDX) of Soft Tissue Sarcomas of patients with sarcomas
时间窗: 4 months
take rate
次要结局
- The passage possibilities of human PDX tumour material by freezing, storing, thawing and re-inoculating in nude mice(4 months after implantation of tumour material)
- To study the passage possibilities of 2D/3D cell cultures by freezing, storing and thawing(1 month)
- Fractionation sensitivity on several STS subtypes in PDX.(4 months)
