Pilot Study to Evaluate Substances in Sweat, Saliva, and Blood
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Predictive performance of the home-based sampling
研究概览
简要总结
This trial collects and analyzes sweat and saliva samples compared to blood in detecting chemical concentrations in the body in patients with chronic or infectious diseases receiving medications. Wearable sweat sensors are capable of monitoring electrolytes and metabolites (sodium, potassium, glucose, lactate, etc.) for health monitoring and disease diagnosis. Designing wearable sweat sensors capable of providing information regarding drug administration may be challenging due to ultralow concentrations in biofluids. This trial seeks to determine if the use of a smart wristband can accurately measure the levels of chemicals and substances in sweat.
详细描述
PRIMARY OBJECTIVE:
I. To compare novel, home-based methods of quantitating medication concentrations in either saliva or sweat to the 'gold standard' of liquid chromatography - mass spectrometry of plasma.
SECONDARY OBJECTIVES:
I. To compare novel home-based methods of quantitating substances in either saliva or sweat to the 'gold standard' in plasma.
II. Assess the ease of obtaining home-based samples.
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
- •Scheduled to receive medications including, but not limited to, cyclophosphamide, mycophenolic acid, mycophenolate mofetil, metformin or busulfan (any dose, any number of doses, any dosing frequency) as part of treatment at any time. Patients with chronic or infectious diseases can participate
- •Willingness to:
- •Provide blood, sweat, and saliva samples
- •Permit medical record review
排除标准
- •Pilocarpine allergy
- •Difficulty with understanding written English
结局指标
主要结局
Predictive performance of the home-based sampling
时间窗: Up to 4 hours
Will be assessed by Pearson correlation and quantification of the predictive performance. The predictive performance of the home-based sampling methods will be assessed by calculating the median percentage prediction error (MPPE).
Observed plasma concentrations
时间窗: Up to 4 hours
Will be assessed by Pearson correlation and quantification of the predictive performance. The values from plasma will be considered the observed concentration.
次要结局
未报告次要终点