Capillary-Venous Paired Data Collection
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- Entia Ltd
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Coefficient of Variance of the difference between the lab results and the Liberty results
研究概览
简要总结
Capillary-venous paired data collection.
详细描述
An iterative data collection study to continuously assess the performance of our Entia Liberty device with cancer patients and healthy volunteers. Our device enables a full blood count from a finger prick sample. The participants enrolled in the study will attend the study site for their routine venepuncture blood test. Once enrolled, they will have a finger prick test obtained by a Healthcare Professional (trained member of the clinical research team) to be tested on an Entia Liberty device. Within 4 hours of that same participant's routine venepuncture, a small amount of blood from the venepuncture will be also tested on a second Entia Liberty device in the laboratory. All the results from the capillary finger prick Liberty test, routine venepuncture blood test (gold standard reference method) and the venous blood Liberty test will be compared against each other to regularly assess that the improvements made on the measurement system of the device is sufficient.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CANCER COHORT:
- •Subjects fulfilling all of the following inclusion criteria are eligible for the study:
- •Age ≥18 years old at the time of study entry
- •Currently receiving standard-of-care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy
- •Scheduled to be undergoing routine venous laboratory blood tests as part of the standard of care
- •Able to provide capillary whole blood donation from pricking three different fingers on one hand
- •Can provide written informed consent
- •In the Investigator's opinion, is able and willing to comply with all study requirements
- •The presence of any one of the following
排除标准
- •will lead to the exclusion of the subject:
- •History or current diagnosis of haematological malignancy (including bone and lymph)
- •Inadequate use and understanding of the English language, requiring a translator
- •HEALTHY COHORT
- •Subjects fulfilling all of the following inclusion criteria are eligible for the study:
- •Age ≥18 years old at the time of study entry
- •Can provide written informed consent
- •Have an NHS number (to enable ordering and tracking of laboratory FBC tests)
- •Registered with a GP
- •In the Investigator's opinion, is able and willing to comply with all study requirements
- •The presence of any one of the following exclusion criteria will lead to the exclusion of the subject:
- •Inadequate use and understanding of the English language, requiring a translator
- •Been hospitalised within 90 days prior to their study visit
- •Donated whole blood or plasma to a blood bank within the 90 days prior to the study visit
- •History of vasovagal syncope following blood draw
- •History or current diagnosis of the following conditions:
- •Cardiovascular disease
- •Chronic kidney disease or end-stage renal disease
- •Bleeding disorder (including but not limited to Immune Thrombocytopenia (ITP), hemophilia, von Willebrand disease (VWD))
- •Blood clotting disorder (including but not limited to thrombophilia, antiphospholipid syndrome)
- •G6PD deficiency
- •Inflammatory bowel disease
- •Myelodysplastic syndrome
- •Tuberculosis
- •Hepatitis B or C
- •Current diagnosis of Epstein-Barr Virus or Cytomegalovirus
- •Current diagnosis of diabetes mellitus, unless controlled by diet alone OR participant has been taking the same dose of the same medication for 4 weeks or more and are feeling fit and well.
- •Undergone organ transplantation
- •Anemia, unless the participant is feeling fit and well (no dizziness, fatigue, shortness of breath etc)
结局指标
主要结局
Coefficient of Variance of the difference between the lab results and the Liberty results
时间窗: 3 years
the coefficient of variance (CV) between the lab results and the liberty results would be compared. a lower CV value signifies a better performance of our device.
Bias (including %bias and absolute bias) between the lab results and the Liberty results
时间窗: 3 years
Bias and absolute difference between the lab results and the liberty results would be compared. a lower bias signifies a better performance of our device.
Regression between the lab results and the Liberty results
时间窗: 3 years
Regression between the lab results and the liberty results would be compared. a value closer to 1.00 signifies a better performance of the Liberty device
次要结局
- Correlation between the Liberty results of different specimen types (capillary blood vs venous blood)(3 yaers)
- Correlation between the performance of Liberty device between cancer patients and healthy volunteers(3 years)