Circulating Tumour Protein Quantification From Capillary Blood for Patient Selfsampling and Safe Remote Monitoring of Multiple Myeloma During COVID-19
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Validated FLC
研究概览
简要总结
The coronavirus (COVID-19) pandemic has brought severe challenges for myeloma patients. Myeloma patients are considered ultra-high risk for COVID-19 and fall into the strictest group for shielding. When on treatment, but also during times of active surveillance, patients have to regularly and frequently leave shielding and visit the hospital for blood tests to monitor their disese. This is specifically for quantification of circulating tumour protein biomarker tests for paraprotein (PP) and/or serum free light chains (sFLCs) by specialised biochemistry units.
This research aims to evaluate the potential use of an at-home patient administered technique to sample blood. The purpose of the blood sampling technique is to monitor your disease status. We want to test if it is possible to monitor a patient's disease status using this alternative blood collection method when compared to monitoring disease status using the traditional blood collection methods (venous blood sampling).
The new VAMS method is not intended to be used interchangeably or will not replace the current method. This study is to evaluate an alternative sample type that may be used to improve the patient pathway, especially during these uncertain times.
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
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of a B-cell dyscrasia
- •Measurable disease by serum free light chain assay
- •Signed informed consent
排除标准
- •Patients <21 years of age
- •Cognitive impairment
- •Non-B Cell Dyscrasia patients
结局指标
主要结局
Validated FLC
时间窗: 6 months
Validated FLC method for use with VAMS that conforms to ISO15189:2012 accreditation
次要结局
未报告次要终点
