Identifying diagnostic criteria for hyperviscosity syndrome in Waldenström Macroglobulinemia
Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT04898647 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with Waldenström Macroglobulinemia who may require treatment initiation due to hyperviscosity.
Not a fit: Patients with other chronic B-cell malignancies or those with histologic transformation of WM may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Amiens
- CHU Amiens — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Magalie JORIS, MD
- Email: joris.magalie@chu-amiens.fr
- Phone: 03 22 45 54 19
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.