Affinity: Hospital Trial. Early Prototype Testing for a Home Oncology Monitoring System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Entia Ltd
- 入组人数
- 247
- 试验地点
- 1
- 主要终点
- To assess the accuracy (bias) of the Affinity prototype device against laboratory testing (capillary vs. venous sample)
研究概览
简要总结
Method comparison study to compare the Affinity prototype device using a capillary blood sample against routine venous laboratory results, in patients undergoing systemic anti-cancer therapy (SACT). Tests will be performed by healthcare professionals (Cohort 1) and participants self-testing (Cohort 2)
详细描述
In this study the Investigators wish to compare 200 finger prick sample (capillary) blood results taken and analysed using the Affinity prototype device to standard of care venous blood samples, taken from the participant on the same day. The blood tests will analyse Full Blood Count (FBC)
200 patients will be recruited in total. 100 will take part in Cohort 1, where a member of the clinical research team will take their blood sample using the Affinity prototype device. The other 100 will take part in Cohort 2, where the participant will self test and take the blood sample themselves. Participants will be asked to complete a short questionnaire after using the device to provide any feedback on its design and use.
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
- •Age >18 years old at the time of study entry Currently receiving standard of care systemic anti-cancer therapy for solid organ malignancy and has received at least one cycle
- •Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care
- •Can provide written informed consent
- •Cohort 2 only- Able to independently complete participant questionnaires
排除标准
- •Receiving systemic anti-cancer therapy for a haematological malignancy
- •Known parasitic infection
- •Known inherited or acquired bleeding disorder
- •History of haematological malignancy
- •Known poorly controlled anti-coagulation
- •Cohort 2 only- Participant or carer unable or unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result
结局指标
主要结局
To assess the accuracy (bias) of the Affinity prototype device against laboratory testing (capillary vs. venous sample)
时间窗: 1 year
Measuring Full Blood Count (FBC)
次要结局
- Assessment and feedback(1 year)