About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of Waldenström's Macroglobulinemia with symptoms of peripheral neuropathy for further clinical investigation.
Disqualifiers
Investigated with no sign of peripheral neuropathy
Trial population
Active diagnose of Waldenström's Macroglobulinemia under follow-up or has been followed at Rigshospitalet Department of Hematology.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Prevalence of peripheral neuropathy associated to Waldenström Macroglobulinema (WM)
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.
Secondary outcomes
Disability of WM associated polyneuropathy
The severity of WM associated neuropathy will be assesed by neuropathy scores - INCAT disability score (a scale of 0-10 with higher scores indicating greater disability.) * MRC 80 sum score (0-80. Lower score indicating more severe paralysis) * INCAT sensory sum score (0-20 with with higher scores indicating greater sensory abnormalities) * Modified Rankin scale: numbered 0 to 6, with higher scores indicating greater disability.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.