试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Entia Ltd
- 入组人数
- 180
- 主要终点
- Validity of of the Liberty System for haematological parameters of interest: Hb, WBC, PLT, ANC
研究概览
简要总结
Entia is a health technology company that has developed a blood testing device called Entia Liberty, which analyses blood collected by a finger prick. Entia is sponsoring this research study to compare the results from Entia Liberty finger prick tests to results from the gold-standard laboratory analyser that tests blood from the arm, port, or PICC line.
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
- 否
入选标准
- •Age ≥ 18 years old at the time of study entry
- •Patients undergoing systemic anti-cancer therapy (SACT)
- •Patients capable of providing written informed consent
- •Patients undergoing routine Full Blood Count (FBC) laboratory blood tests as part of the standard of care
- •Additional inclusion criteria:
- •Phase 1 (Longitudinal, low count data): Neutrophil Count ≤ 1.0 x109/L within 24 hours preceding consenting
- •Phase 2 (Low count data): Neutrophil Count ≤ 1.5 x109/L within 24 hours preceding consenting
排除标准
- •History or current diagnosis of haematological malignancy
- •Inadequate use and understanding of the English language, requiring a translator
研究组 & 干预措施
Phase 1
Participants who have undergone a laboratory FBC test that has returned a neutrophil count of ≤ 1.0 x109/L who can be consented within 24 hours of the result.
Participants will donate one finger prick sample up to once per day to be tested on the Liberty device.
干预措施: Entia Liberty System (Device)
Phase 2
Participants who have undergone a laboratory FBC test that has returned a neutrophil count of ≤ 1.5 x109/L who can be consented within 24 hours of the result.
Participants will donate up to 3 finger prick samples to be tested on the Liberty device in a single session.
干预措施: Entia Liberty System (Device)
Phase 3
Participants who are undergoing a routine venous draw as part of the standard of care as part of SACT toxicity monitoring.
Participants will donate up to 3 finger prick samples to be tested on the Liberty device in a single session.
干预措施: Entia Liberty System (Device)
结局指标
主要结局
Validity of of the Liberty System for haematological parameters of interest: Hb, WBC, PLT, ANC
时间窗: Through study completion, up to 8 days per participant.
The accuracy of the Liberty System will be measured by comparing the results of finger-prick blood samples that have been analysed using the Liberty System to the results of venous (blood from the arm, port or PICC line) blood samples that have been analysed by a standard laboratory haematology analyser.
Reliability of of the Liberty System for haematological parameters of interest: Hb, WBC, PLT, ANC
时间窗: Through study completion, up to 8 days per participant.
To measure the precision of the Liberty System by comparing the results of finger-prick blood samples that have been analysed by the Liberty System to each other, and to venous (blood from the arm, port or PICC line) blood samples that have been analysed by the Liberty System.
次要结局
未报告次要终点