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临床试验/NCT06876298
NCT06876298尚未招募不适用

Role of Uromodulin in Management of Multiple Myloma

Assiut University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年3月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
2
主要终点
To assess the predictive value of serum uromodulin level in newly diagnosed patients with multiple myeloma with and without renal impairment as non-invasive marker for myeloma cast nephropathy..

研究概览

简要总结

• To Evaluate the role of uromodulin level in early diagnosis of cast nephropathy and to detect its prognostic value in multiple myeloma patients

详细描述

Multiple myeloma (MM) is a malignant plasma cell disorder . It is the second most common hematologic malignancy worldwide . It accounts for 15%-20% of all hematologic malignancies and has a 5-year survival rate of 60% .

About 31% of newly diagnosed MM patients presented with renal impairment and about 6% to 13% need dialysis , which significantly increases morbidity and mortality, and limits treatment strategies . Most common renal disease in MM is myeloma cast nephropathy that derived from secreted free light chains that combined with uromodulin to form cast which obstructs the distal tubules and presented with severe acute kidney injury . Renal biopsy is the only method to accurately diagnose myeloma cast nephropathy.

Uromodulin, also known as Tamm-Horsfall protein, is a kidney specific glycoprotein which is produced only by the epithelial cells lining the thick ascending limb (85%-90%) and early distal convoluted tubule (10%-15%), and is released to urine and blood . About 200 mg/day of uromodulin is normally excreted in urine . Recently, uromodulin being involved in many pathological processes as hypertension, urinary tract infections, nephrolithiasis, chronic and acute kidney disease.

Limited is known about role of uromodulin in management of myeloma. Measurement of serum uromodulin in patients that newly diagnosed multiple myeloma with and without renal impairment and follow up these patients for 1 year may provide a useful non-invasive predictor of cast nephropathy and may has a prognostic value in myeloma.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients ≥ 18 years old that newly diagnosed with multiple myeloma according to 2024 updates in diagnosis of multiple myeloma (10) with and without renal impairment at nephrology and haematology unit of internal medicine department.

排除标准

  • any patient have evidence of renal impairment due to any cause other than multiple myeloma as diabetic nephropathy, hypertensive nephropathy or lupus nephritis ... etc.

结局指标

主要结局

To assess the predictive value of serum uromodulin level in newly diagnosed patients with multiple myeloma with and without renal impairment as non-invasive marker for myeloma cast nephropathy..

时间窗: 1 year

measurement of serum uromodulin level by ELISA technique in newly diagnosed patients with multiple myeloma with and without renal impairment at 3 times during course Bortizomib based chemotherapy to assess if serum uromodulin level is higher in patients with multiple myloma and renal impairment than in those without renal impairment and to detect the most accurate time to measure serum uromodulin during the treatment course.

次要结局

  • To detect correlation between serum uromodulin level and risk stratification, staging and prognosis of newly diagnosed patients with multiple myeloma.(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Usra Mohamed Farag

Usra Mohamed farrag Ahmed

Assiut University

研究点 (2)

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Role of Uromodulin in Management of Multiple Myloma | 临床试验