Q-SAM (Using QPOP to Predict Treatment for Sarcomas and Melanomas)
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
- Percentage of patients with successful model generation for each tumour subtype.
研究概览
简要总结
This is a multi-cohort proof of concept study involving patients with sarcomas or melanomas. Patient models, both two- and three-dimensional, will be derived from tumour samples. These will then be used to evaluate drug sensitivities ex vivo.
Enrolled patients will undergo resections or biopsies as part of standard-of-care, which will be used to generate patient models. Patients will receive standard-of-care systemic treatment. Patient models will also be subjected up to a 14-drug screening panel. The majority of drugs in the respective drug panels has been shown to have activity in the respective cancers and would be used in the standard-of-care setting by treating physicians.
详细描述
Hypothesis
Ex vivo drug testing on patient-derived models using QPOP can identify drug sensitivities and combinations which may have clinical efficacy against sarcomas and melanomas.
Specific aim 1: To derive patient models, both two- and three-dimensional, of sarcomas and melanomas
Specific aim 2: To perform ex vivo drug testing on patient models of sarcoma and melanoma using QPOP
Specific aim 3: To assess the efficacy of phenotype directed therapy using QPOP to assign treatment after progression on standard-of-care treatment in sarcoma and melanoma
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
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of sarcoma or melanoma
- •At least 1 tumour lesion amenable to fresh biopsy or resection
- •Signed informed consent from patient or legal representative
- •Able to comply with study-related procedures
排除标准
- •There are no specific exclusion criteria if patients meet the inclusion criteria
结局指标
主要结局
Percentage of patients with successful model generation for each tumour subtype.
时间窗: 8 years.
Patients enrolled on study will undergo resection or biopsy of fresh tumour tissue to obtain cells for the generation of models.
Survival outcomes from QPOP-directed treatment regimens.
时间窗: 8 years.
Overall survival, progression-free survival.
Rates of radiological response from QPOP-directed treatment regimens.
时间窗: 8 years.
Complete and partial clinical response and stable disease.
次要结局
未报告次要终点