Actively Recruiting
Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-05-29
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire, Amiens
Lead Sponsor
C
Centre Hospitalier Saint Vincent
Collaborating Sponsor
AI-Summary
What this Trial Is About
Waldenström Macroglobulinemia (WM) is a condition marked by abnormal bone marrow cell growth and the presence of a specific antibody called immunoglobulin M (IgM) in the blood. The study focuses on hyperviscosity syndrome (HVS), a common complication in WM caused by high levels or certain properties of IgM, leading to symptoms like bleeding and fatigue. Researchers aim to develop a clear diagnostic system for HVS based on both objective signs such as eye exam findings and subjective symptoms including fatigue and related health problems. The research involves evaluating patients with WM who may need treatment, including those with a high serum monoclonal component or those undergoing hyperviscosity assessment. Participants will undergo fundoscopic imaging reviewed centrally, blood collection for various analyses including expression studies, and bone marrow sampling for molecular study. Patients are grouped based on the confirmation or absence of HVS, and the study is non-randomized without blinding. During the three-year study, participants will complete questionnaires and undergo eye examinations to correlate symptoms and findings with the presence of HVS. Blood and bone marrow samples will be collected to better understand the disease characteristics. The study is designed to monitor these assessments over time to identify reliable ways to detect HVS and guide treatment decisions. Participants must consent to the study and will be followed according to the schedule outlined by the research team.
CONDITIONS
Brief Title
Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with Waldenström Macroglobulinemia
- 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 undergo hyperviscosity assessment
- Patients agreeing to give informed consent
You will not qualify if you...
- Patients with another chronic B-cell malignancy
- Patients with lymphoplasmacytic proliferations
- Patients with marginal zone lymphoma
- Patients with Waldenström Macroglobulinemia and histologic transformation
- Absence of informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants undergo assessments including fundoscopic pictures, blood samples, and bone marrow samples to evaluate hyperviscosity syndrome and related characteristics.
Visits scheduled according to clinical need for sample collection and assessments
Trial Site Locations
Total: 1 location
1
CHU Amiens
Amiens, France, 80480
Actively Recruiting
Research Team
M
Magalie JORIS, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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