A Comparator Study of a Tasso Device to Traditional Venous Blood Sampling Methods for Complete Blood Count (CBC) With 5-part Differential in Patients With Leukemia, Lymphoma, and/or Other Blood Cell Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Tasso Inc.
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Agreement between capillary and venous blood in the measurement of White Blood Cells and Absolute Neutrophil Count
研究概览
简要总结
This study will evaluate the feasibility of using capillary blood samples collected with the Tasso device for analysis of CBC in diseased patients with leukemia, lymphoma, and/or other blood cell disorders.
This investigation will include a minimum of 40 sample sets from unique patients.
详细描述
This study will evaluate the feasibility of using capillary blood samples collected with the Tasso device for analysis of CBC in diseased patients with leukemia, lymphoma, and/or other blood cell disorders.
This investigation will include a minimum of 40 sample sets from unique patients.
The primary aim of this study is to demonstrate the agreement between capillary blood collected using the Tasso device and venous blood collected in a K2EDTA (dipotassium ethylenediaminetetraacetic acid) tube according to established sampling procedures for quantification of WBC and ANC as part of a standard CBC panel with 5-part differential.
The secondary aim of the study is to demonstrate the agreement between Tasso device and venous samples for the measurement of additional analytes evaluated as part of a standard CBC panel with 5-part differential, including PLTs, HGB, RBC, Hct, MCV, lymphocytes, monocytes, eosinophils, and basophils.
An exploratory aim of this research is to evaluate patient acceptance of the Tasso device in a diseased population.
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
- •Willing and able to provide written (or electronic) informed consent prior to study entry
- •At least 18 years of age
- •Requiring a CBC blood test as part of the patient's standard of care
- •Have abnormal laboratory results of either leukopenia, leukocytosis or neutropenia.
- •Normal skin integrity and healthy skin appearance around the capillary collection site (upper arm/shoulder area on at least one side)
排除标准
- •Unable to give full and free consent to participate in a study due to limited capacity or risk of undue influence or coercion (including but not limited to children, prisoners, individuals with diminished decision-making capacity, illiterate or educationally disadvantaged populations) or any other individual who is unable to give full and free consent in the judgement of the investigator
- •At the determination of the treating physician, unsuitable for enrollment due to severe immunocompromised status or other comorbidities.
结局指标
主要结局
Agreement between capillary and venous blood in the measurement of White Blood Cells and Absolute Neutrophil Count
时间窗: Day 1
To demonstrate agreement between capillary blood collected using the Tasso device and traditional venous blood collected using standard methods for measurement of white blood cells (WBCs), and absolute neutrophils count (ANC) as part of a CBC analysis with 5-part differential.
次要结局
- Agreement between capillary and venous blood in the measurement of secondary biomarkers(Day 1)