Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia
NCT ID: NCT04898647
Last Updated: 2025-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
100 participants
INTERVENTIONAL
2021-05-14
2026-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Spanish Registry of Patients With IgM Monoclonal Gammopathies
NCT05093153
Prognostic Analyses on a Validation Series of Patients With Waldenström's Disease
NCT05911802
Plasmapheresis Before Rituximab in Cryoglobulinemia
NCT04692363
INS, B Cells and Microbiota
NCT04924712
Evaluation of Severity in Juvenile and Adult-onset Dermatomyositis
NCT06004817
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with confirmed HVS
presence of unexplained elsewhere fundoscopic abnormalities AND either IgM concentration above 30 g/L (densitometry) or cryoglobulin activity
fundoscopic picture
A central review of numerised fundoscopic picture will be performed.
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
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
Patients with confirmed absence of HVS
fundoscopic picture
A central review of numerised fundoscopic picture will be performed.
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
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
Remaining patients
fundoscopic picture
A central review of numerised fundoscopic picture will be performed.
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
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
fundoscopic picture
A central review of numerised fundoscopic picture will be performed.
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
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 lymphoplasmacytic proliferations
* patients with marginal zone lymphoma.
* patients with WM and histologic transformation
* Absence of informed consent.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Saint Vincent
UNKNOWN
Centre Henri Becquerel
OTHER
University Hospital, Caen
OTHER
University Hospital, Lille
OTHER
Centre Hospitalier de Lens
OTHER
Centre Hospitalier Universitaire, Amiens
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Amiens
Amiens, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PI2020_843_0109
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.