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临床试验/NCT07160270
NCT07160270招募中不适用

Neuropathy in Waldenström's Macroglobulinemia: Pathophysiology, Prognosis and Treatment

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年5月14日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
Prevalence of peripheral neuropathy associated to Waldenström Macroglobulinema (WM)

研究概览

简要总结

Neuropathy severely reduces patients' quality of life due to sensory loss, chronic neuropathic pain, and loss of mobility of arms and legs. Given the diverse origins of neuropathy, it is critical to identify its specific causes, particularly when effective treatments are available. Neuropathy is a frequent morbidity in Waldenström's macroglobulinemia (WM), a specific type of lymphoma caused by infiltration of clonal lymphoplasmocytic B cells in the bone marrow with the presence of IgM paraprotein. WM associated neuropathy is largely undescribed. The few existing studies are mostly retrospective indicating the neuropathy has a heterogenic pathophysiology and diverse clinical appearance from mild sensory neuropathy to aggressive with loss of ambulation and development of chronic neuropathic pain within weeks to months.

With treatment of WM the speed of the disease progression including the related neuropathy can be halted. Few studies and clinical experience indicate that the nerve damage induced by WM might remit if treatment is initiated early in the course of the disease. Thus, there is need for timely interventions to reduce chronic disabilities. However, even for an experienced neurologist, it can be difficult to identify whether the neuropathy is caused by WM or other causes where treatment is not indicated.

This project aims to investigate the prevalence and underlying mechanisms of neuropathy in patients with WM to help speed up the diagnostic process and thus help slow down the irreversible nerve damage that these patients experience.

详细描述

Methods

Study design: Cross-sectional observations study

Outcome:

Prevalence: Determining how many WM patients have neuropathy.

Characterization: Identification of clinical subtypes of WM associated neuropathy and their symptoms.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Diagnosis of Waldenström's Macroglobulinemia with symptoms of peripheral neuropathy for further clinical investigation.

排除标准

  • Investigated with no sign of peripheral neuropathy

结局指标

主要结局

Prevalence of peripheral neuropathy associated to Waldenström Macroglobulinema (WM)

时间窗: From enrollment from August 2024 and new diagnosed patients with WM and symptoms of neuropathy refered to the neuromuscular clinic until July 2025.

The prevalence will be calculated by screening WM patients with a questionnaire designed specific for the research project to identify possible peripheral neuropathy. Patients with possible peripheral neuropathy will be clinical examined to either positiv og negative for peripheral neuropathy and confirmed by nerve conduction study. The prevalence will be the amount of patient with polyneuropathy in the population of investigated patientes with WM.

次要结局

  • Disability of WM associated polyneuropathy(Investigation during one year with follow up for 3 years)

研究者

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

Morten Müller Aagaard

Medical doctor

Rigshospitalet, Denmark

研究点 (1)

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