Actively Recruiting

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ID07160270

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

Led by Rigshospitalet, Denmark · Updated on 2025-09-08

90

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Neuropathy greatly impacts patients by causing sensory loss, chronic pain, and difficulty moving arms and legs. This research focuses on neuropathy linked to Waldenstrm's Macroglobulinemia (WM), a specific lymphoma type involving abnormal B cells and IgM protein. WM-related neuropathy varies widely, from mild symptoms to severe loss of movement and pain. Early treatment of WM may slow disease and nerve damage, but identifying neuropathy caused by WM versus other reasons can be challenging. The study is a cross-sectional observational design aiming to find how common neuropathy is among WM patients and to understand its clinical subtypes and underlying mechanisms. Researchers will use questionnaires, neurological exams, nerve conduction studies, blood tests, and cerebrospinal fluid analysis to investigate patients. About 90 patients with symptoms of neuropathy associated with WM will be clinically examined and tested over one year, with a three-year follow-up period. Participants will complete questionnaires and undergo physical and paraclinical assessments including nerve conduction studies and sample collections. Blood tests will analyze markers related to neuropathy, inflammation, and infections, while cerebrospinal fluid will be tested for related proteins and cells. The study will measure how many WM patients have neuropathy and assess the disability caused by it. Data will help improve diagnosis, monitoring, and treatment approaches to maintain patient mobility and quality of life.

CONDITIONS

Brief Title

This Study Aims to Clarify the Prevalence and Characteristics of Neuropathy, Along With Associated Paraclinical Findings in Patients With Waldenström's Macroglobulinemia (WM) in a Cohort of WM Patients to Optimize the Diagnostic Process

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Waldenstr�m's Macroglobulinemia with symptoms of peripheral neuropathy for further clinical investigation.
Not Eligible

You will not qualify if you...

  • Investigated with no sign of peripheral neuropathy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 year

Participants with probable neuropathy undergo clinical neurological examination and nerve conduction studies to confirm and classify neuropathy.

1 to 2 visits depending on clinical findings

Sample Collection

Duration - Up to 1 year

Participants with confirmed neuropathy provide blood samples and cerebrospinal fluid for biomarker analysis and other paraclinical tests.

1 to 2 visits for blood sampling and lumbar puncture

Long-term Monitoring

Duration - 3 years

Participants are followed for up to 3 years to monitor disability progression and neuropathy outcomes.

Periodic assessments during follow-up (visit schedule may vary)

Trial Site Locations

Total: 1 location

1

Copenhagen Neuromuscular Center, Rigshospitalet Blegdamsvej.

København Ø, Denmark, 2100

Actively Recruiting

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Research Team

M

Morten Müller Aagaard, Medical Doctor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Report of consensus panel 1 from the 11th International Workshop on Waldenstrom's Macroglobulinemia on management of symptomatic, treatment-naïve patients.

Christian Buske, Jorge J Castillo, Jithma Prasad Abeykoon...

https://pubmed.ncbi.nlm.nih.gov/37099027

Investigation and management of IgM and Waldenström-associated peripheral neuropathies: recommendations from the IWWM-8 consensus panel.

Shirley D'Sa, Marie José Kersten, Jorge J Castillo...

https://pubmed.ncbi.nlm.nih.gov/28198999

Treatment recommendations for patients with Waldenström macroglobulinemia (WM) and related disorders: IWWM-7 consensus.

Meletios A Dimopoulos, Efstathios Kastritis, Roger G Owen...

https://pubmed.ncbi.nlm.nih.gov/25027391

Central nervous system involvement by Waldenström macroglobulinaemia (Bing-Neel syndrome): a multi-institutional retrospective study.

Jorge J Castillo, Shirley D'Sa, Michael P Lunn...

https://pubmed.ncbi.nlm.nih.gov/26686858

Heterogeneous spectrum of neuropathies in Waldenström's macroglobulinemia: a diagnostic strategy to optimize their management.

Karine Viala, Tanya Stojkovic, Anne-Violaine Doncker...

https://pubmed.ncbi.nlm.nih.gov/22462670

Waldenström Macroglobulinemia - A State-of-the-Art Review: Part 1: Epidemiology, Pathogenesis, Clinicopathologic Characteristics, Differential Diagnosis, Risk Stratification, and Clinical Problems.

Michele Bibas, Shayna Sarosiek, Jorge J Castillo

https://pubmed.ncbi.nlm.nih.gov/38984103