Correlation Between the Urinary Protein/Creatinine Ratio in a Single Urine Sample Versus 24-hour Proteinuria in Patients With Multiple Myeloma.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- change in urinary protein/creatinine ratio
研究概览
简要总结
The measurement of 24-hour proteinuria allows an assessment of treatment response in patients with multiple myeloma. But it is difficult and restrictive to make.
This study was therefore designed to investigate the correlation between the ratio of proteinuria / creatinine on samples, easier to obtain, and the 24-hour proteinuria in assessing response to this treatment .
详细描述
The measure of 24-hour proteinuria is an important biomarker for multiple myeloma.
Multiple myeloma is often accompanied by proteinuria overhead of secretion by plasma cells of large quantities of immunoglobulin free light chains (FLC) kappa or lambda. This proteinuria is composed of monoclonal FLC. The measure of the urinary concentration of FLC is an important biomarker for both diagnosis and evaluation of response to treatment of light chain multiple myeloma but also in intact immunoglobulins multiple myeloma.
The 24-hour proteinuria coupled with urine protein electrophoresis is the standard method for measuring the concentration of urinary FLC. However, it is difficult to obtain a reliable collection of the urine of 24 hours which can make it difficult to assess response to therapy in some patients. It would be interesting to assess proteinuria in a single urine sample collected at any time of day.
Contribution of urinary protein/creatinine ratio for assessment of proteinuria of glomerular origine.
For reasons of convenience, the extent of 24-hour proteinuria was increasingly abandoned by nephrologists in favor of urinary protein/creatinine ratio (UPCR). The use of UPCR measured on a sample of urine overcomes the inaccuracies related to the collection of 24 or variations in urine concentration. This report has been validated against the 24-hour proteinuria for screening or monitoring of renal glomerular diseases by the French Society of Nephrology. In theory, the UPCR is measured on a urine sample, taken preferably in the morning. In practice, the precision of a measurement at any time of day is quite acceptable.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For the first part of the study :
- •adult patient
- •giving a free, informed and written consent
- •patient having a follow-up in the service for multiple myeloma, whatever the age of diagnosis, the isotype of monoclonal component, stage and disease activity
- •patient hospitalized in the service whatever the reason for hospitalization (related or not with multiple myeloma)
- •proteinuria ≥ 500 mg/24h
- •percentage of albuminuria < 50% on urinary protein electrophoresis
- •presence of immunoglobulin FLC in immunofixation of urine proteins
- •For the second part of the study :
- •adult patient
- •giving a free, informed and written consent
- •patient having a follow-up in the service for multiple myeloma, whatever the age of diagnosis, the isotype of monoclonal component
- •requiring the initiation of treatment with chemotherapy
- •proteinuria ≥ 500 mg/24h
- •percentage of albuminuria < 50% on urinary protein electrophoresis
- •presence of immunoglobulin FLC in urine proteins immunofixation
排除标准
- •minor patient
- •proteinuria < 500 mg/24h
- •predominantly glomerular proteinuria with ≥ 50% albumin on urinary protein electrophoresis
- •absence of immunoglobulin FLC in urine proteins immunofixation
- •progressive urinary infection
- •patient with a glomerular nephropathy
- •macroscopic hematuria
- •patient unable to perform a urinary collection for 24 hours
- •patient unable to give a consent
- •pregnant or lactating woman
结局指标
主要结局
change in urinary protein/creatinine ratio
时间窗: Change from baseline in urinary protein/creatinine ratio at 8 AM, 12 AM, 4 PM
To study the correlation between the urinary protein/creatinine ratio in the sample and 24-hour proteinuria in the assessment of treatment response in patients with multiple myeloma.
次要结局
- changes in urinary excretion of FLC(Of the 24-hour urine, at 8 AM, 12 AM, 4 PM)
- methods for estimating the urinary concentration of FLC(Of the 24-hour urine, at 8 AM, 12 AM, 4 PM)