Identifying diagnostic criteria for hyperviscosity syndrome in Waldenström Macroglobulinemia
Official title: Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia
Run by Centre Hospitalier Universitaire, Amiens · NCT04898647 · Data updated 2026-11-12
This study is trying to create better guidelines to diagnose hyperviscosity syndrome in people with Waldenström Macroglobulinemia by looking at both their symptoms and test results.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Status | Recruiting |
| Started | May 14, 2021 |
| Main results expected | August 2025 |
| Study ends | August 2026 |
| Registry record updated | May 29, 2025 |
| Trial ID | NCT04898647 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients diagnosed with Waldenström Macroglobulinemia who may require treatment initiation due to hyperviscosity.
✕Probably not a fit
Patients with other chronic B-cell malignancies or those with histologic transformation of WM may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical study focuses on patients with Waldenström Macroglobulinemia (WM) to develop a diagnostic system for hyperviscosity syndrome (HVS). It aims to evaluate both objective symptoms, such as bleeding and fundoscopic findings, and subjective symptoms like fatigue and comorbidities that may affect symptom severity. Patients will undergo assessments including fundoscopic pictures, blood samples, and bone marrow samples to gather comprehensive data. The study seeks to establish clearer diagnostic criteria for HVS, which is often a reason for initiating therapy in WM patients.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic criteria for hyperviscosity syndrome, enhancing treatment decisions for patients with Waldenström Macroglobulinemia.
How similar studies have gone: While there is limited research specifically on hyperviscosity syndrome in WM, the study aims to fill a gap in existing literature, suggesting a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with WM * Patients that may require a first-line or subsequent-line therapy * patients who will require treatment initiation * patients with serum monoclonal component concentration greater than 15 g/L and who will underwent hyperviscosity assessment, even if hyperviscosity is not found and in the absence of other treatment criteria, no treatment is finally initiated. * Patients agreeing to give informed consent. Exclusion Criteria: * Patients with another chronic B-cell malignancy * patients with lymphoplasmacytic proliferations * patients with marginal zone lymphoma. * patients with WM and histologic transformation * Absence of informed consent.
Where it's running
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CHU Amiens
Amiens, France Recruiting
Study contacts
- Study coordinator: Magalie JORIS, MD
- Email: joris.magalie@chu-amiens.fr
- Phone: 03 22 45 54 19
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.