NOTION: iN-home Sampling Of cyTokines in ImmunOtherapy patieNts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Patient adherence to protocol defined DBS time points.
研究概览
简要总结
This study will explore the ability of patients on first line combination immunotherapy to sample cytokines at home. The data from this study will be used to evaluate the feasibility of in-home testing and the ability to analyse patients cytokine profiles retrospectively to help feed the development of further studies.
详细描述
Patients will be informed of the study and given a minimum of 24 hours to consider. Once consented patients will enter the study where they will take cytokine samples at home over a 12 week period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Voluntary informed consent.
- •Aged at least 18 years.
- •Diagnosis of locally advanced or metastatic RCC, Melanoma or NSCLC
- •In the opinion of the investigator deemed suitable to receive first-line combination immunotherapy (RCC and MM) or combination immunotherapy and chemotherapy (NSCLC).
- •Willingness to comply with scheduled trial procedures.
- •Capable of performing own dry blood sampling procedure, or a carer who is willing and able to perform them.
排除标准
- •Previous immunotherapy (including any CPI either as single agent on in combination, or high dose interleukin-2).
- •Judgement by the investigator that the individual should not participate if they are unlikely to comply with study procedures and requirements.
- •Patients receiving long term oral anticoagulation deemed by the clinician to be at risk from daily finger pricking.
结局指标
主要结局
Patient adherence to protocol defined DBS time points.
时间窗: 12 months
the number of DBS samples successfully collected against the number of total expected samples
Number of in-home DBS samples passing quality assurance checks in patients receiving CPI therapy by multi-cytokine ELISA.
时间窗: 12 months
the number of DBS samples passing quality assurance checks against the number of DBS samples successfully collected.
次要结局
- Compare cytokine concentrations by DBS sampling and intravenous blood sampling by multi-cytokine ELISA.(12 months)