An interventional study of fundoscopic picture and blood sample in Hyperviscosity Syndrome and Waldenstrom Macroglobulinemia, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-29.
Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Other
Walsdenström Macroglobulinemia (WM) is defined by a bone marrow lymphoplasmacytic infiltration and the presence of a monoclonal immunoglobulin M (IgM) in blood. Clinical manifestations of the hyperviscosity syndrome (HVS) are related to the large amount of IgM in circulating blood or to some physicochemical characteristics such as the presence of a cryoglobulin property. Although HVS is one of the most frequent criteria for initiating therapy in WM, few studies focused on its description and no diagnostic criteria are available.
The present study aims to identify a diagnostic system for HVS, taking into account objective symptoms such as bleedings, fundoscopic findings and also subjective symptoms such as fatigue and comorbidities that may influence the severity of symptoms.
365 studies on the registry are indexed under Waldenstrom Macroglobulinemia; 62 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 316 interventional studies indexed under Waldenstrom Macroglobulinemia.
Browse Waldenstrom Macroglobulinemia studies →Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
presence of unexplained elsewhere fundoscopic abnormalities AND either IgM concentration above 30 g/L (densitometry) or cryoglobulin activity
Other: fundoscopic picture · Biological: blood sample · Procedure: bone marrow sample
Other: fundoscopic picture · Biological: blood sample · Procedure: bone marrow sample
Other: fundoscopic picture · Biological: blood sample · Procedure: bone marrow sample
A central review of numerised fundoscopic picture will be performed.
Two 10 ml blood vials will be sampled in addition to standard blood sampling for getting 6 to 7 200 μL aliquot. One 5 ml EDTA vial for GP1bα expression study, only if this sample can be sent to hemostasis laboratory within the 4 hours after sampling
Five to 10 ml bone marrow sample will be collected in addition to standard bone marrow sampling for getting molecular characteristics of WM
Correlation between items collected in questionnaires and HVS detection
Correlation between items collected in questionnaires and HVS detection. Questionnaires are An oncogeriatric form for geriatric assessment, a comorbidity assessment form, a fatigue and quality of live assessment form, and an hemorrhagic assessment form.
Time frame: 3 years
Correlation between fundoscopic findings and HVS detection
Correlation between fundoscopic findings and HVS detection
Time frame: 3 years
Plan to share: No
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Waldenstrom Macroglobulinemia→
Centre Hospitalier Universitaire, Amiens