NCT06323447进行中（未招募）不适用
Pivotal Study to Validate the Usability, Safety and Diagnostic Performance of a Novel System to Non-Invasively Detect Severe Neutropenia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 210
- 试验地点
- 6
- 主要终点
- PointCheck Accuracy
研究概览
简要总结
Pivotal study to validate the diagnostic performance of PointCheck, the first non invasive device to preliminary detect neutropenia in cancer patients receiving intermediate/high risk antineoplastic therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand the purpose and risks of the study and to provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
- •Male or Female aged 10 years or above.
- •Diagnosed with either Diffuse Large B Cell Lymphoma or Multiple Myeloma.
- •Scheduled treatment with any antineoplastic therapy with an associated high/intermediate risk of neutropenia according to NCCN guidelines.
- •Able (in the investigator's opinion) and willing to comply with all study requirements.
排除标准
- •Participants with amputations, congenital malformations or any severe abnormalities of the hands as determined by the investigator.
- •Participants with a history of vasculitis, Raynaud syndrome, scleroderma, mixed connective tissue disease or any other rheumatologic systemic condition that could produce microcirculatory changes in the nailfold.
- •Participants with circulating tumour cells in previous or current lab determinations.
- •Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor).
- •Unstable participants or participants with hypotension (systolic blood pressure <90 and diastolic blood pressure < 60mmHg).
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- •Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.
结局指标
主要结局
PointCheck Accuracy
时间窗: Two weeks
The main primary endpoints for this study will be the sensitivity and specificity of PointCheckTM to detect grade IV neutropenia ac cording to the CTCAE V5 definition of severe neutropenia in a standard blood analysis.
次要结局
- PointCheck Usability(Two-weeks)
- PointCheck Precision(Two-weeks)
- PointCheck Safety(Two-weeks)
- PointCheck Errors(Two-weeks)
研究者
研究点 (6)
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