CApillary-VEnous Paired Collection (CAVE)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- Entia Ltd
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- To validate the measurement performance of the investigational system (bias and %bias)
研究概览
简要总结
This study is recruiting participants to donate 3 capillary blood samples to be tested on the investigational system and venous blood to be tested on a comparator system. At the some sites, additional venous blood samples from the same participants will be tested on the investigation system.
The participants' CBC results analyzed on the gold standard laboratory analyzer (comparator) will be collected and compared against the results obtained from the testing of capillary blood samples and venous blood samples on the investigational system. At certain sites, the usability of the investigational system is observed to evaluate the usability of the system.
The participants' involvement in the study is only for the duration of collecting the blood samples. No follow-up is anticipated. The results from the investigational system is for research use only and will not inform or change the participants' treatment or care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent signed by the subject
- •Age ≥21 years old at the time of study entry
- •Currently receiving standard-of-care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and/or targeted therapy) for solid organ malignancy
- •Scheduled to be undergoing routine venous laboratory blood tests as part of the standard of care OR willing to undergo a research-specific venous draw to obtain a complete/full blood count (CBC/FBC)
排除标准
- •History or current diagnosis of hematological malignancy (including bone and lymph)
- •Patients who self-report disabilities or issues with their eyesight, hearing or dexterity that they believe will preclude the use of Liberty, and who do not have a carer who can assist them.
- •Patients who have had prior experience using Liberty
- •Inadequate use and understanding of the English language, requiring a translator
- •Carer eligibility:
- •Age ≥ 21 years old at the time of study entry
- •Can provide written informed consent
- •Do NOT self-report disabilities or issues with their eyesight, hearing or dexterity that they believe will preclude the use of Liberty
- •Have NOT had prior experience using Liberty
- •Adequate use and understanding of the English language; NOT requiring a translator
研究组 & 干预措施
Participants
All participants to undergo the same study method. Where all participants are to donate capillary blood to complete 3 tests on the investigational system and a comparator venous sample for testing on a comparator system. For certain sites, an additional venous sample will also be tested on the investigational system. The venous CBC results from the comparator system will be compared to the results of both capillary and venous specimens obtained by the investigational system.
干预措施: Entia Liberty System (Device)
结局指标
主要结局
To validate the measurement performance of the investigational system (bias and %bias)
时间窗: through study completion, estimated 6 months
The difference between the measured parameters of the comparator and investigational system will provide the bias (and therefore also the % bias) of the investigational system, which will be checked against pre-determined acceptance criteria.
To validate the measurement performance of the investigational system (regression)
时间窗: through study completion, estimated 6 months
The plotted difference between the measured parameters of the comparator and investigational system will provide the regression, which will be checked against pre-determined acceptance criteria.
To validate the measurement performance of the investigational system (CV and SD)
时间窗: through study completion, estimated 6 months
The difference between the measured parameters of the comparator and investigational system will inform the Coefficient of Variation and Standard Deviation of the dataset, which will be checked against pre-determined acceptance criteria.
To validate the measurement performance of the investigational system
时间窗: through study completion, estimated 6 months
The difference between the measured parameters of the comparator and investigational system will provide the bias (and therefore also the % bias) of the investigational system, which will be checked against pre-determined acceptance criteria.
To validate the usability of the Liberty Analyzer System in a simulated home environment
时间窗: Through study completion. Estimated 6 months
Participant to complete a usability questionnaire following use of Liberty. Observer to complete usability checklist during participants' use of Liberty
To prove equivalence in the measurement performance between the sampling matrices
时间窗: through study completion, estimated 6 months
Performance comparison (bias, %bias, regression, CV) between the testing matrices (capillary whole blood and venous whole blood) on Liberty.
次要结局
未报告次要终点