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Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia

NCT04898647 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-05-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

fundoscopic picture

A central review of numerised fundoscopic picture will be performed.

BIOLOGICAL

blood sample

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

PROCEDURE

bone marrow sample

Five to 10 ml bone marrow sample will be collected in addition to standard bone marrow sampling for getting molecular characteristics of WM

Sponsors & Collaborators

  • Centre Hospitalier Saint Vincent

    collaborator UNKNOWN

  • Centre Henri Becquerel

    collaborator OTHER

  • University Hospital, Caen

    collaborator OTHER

  • University Hospital, Lille

    collaborator OTHER

  • Centre Hospitalier de Lens

    collaborator OTHER

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-14
Primary Completion
2025-08-31
Completion
2026-08-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04898647 on ClinicalTrials.gov