ClinicalTrials.gov record NCT04898647
Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia
Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This interventional study in people with Waldenstrom macroglobulinemia aims to develop a diagnostic system for hyperviscosity syndrome by comparing symptoms, eye exam images, blood tests and bone marrow samples. Participants will have fundus photographs centrally reviewed and give extra blood and bone marrow samples in addition to standard care. The study looks for which questionnaire items and fundoscopic findings correlate with detecting hyperviscosity.
What it is studying. Whether a combination of patient-reported symptoms, comorbidity and fatigue questionnaires, bleed assessment, fundoscopic (eye) findings, and laboratory/bone marrow features can form a diagnostic system that correlates with hyperviscosity syndrome in people with Waldenstrom macroglobulinemia.
What the researchers hope to learn. To define diagnostic criteria for hyperviscosity syndrome in Waldenstrom macroglobulinemia and to find which questionnaire items and fundoscopic findings correlate with hyperviscosity detection; to collect molecular data from blood and bone marrow related to these findings.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Biological
- blood sample
- Procedure
- bone marrow sample
- Other
- fundoscopic picture
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will have fundoscopic (back-of-eye) images taken for central review, give extra blood samples (two 10 ml vials plus a possible 5 ml EDTA vial for a GP1bα test if the sample can be sent to the hemostasis lab within 4 hours), and provide an extra bone marrow sample (5–10 ml) in addition to standard bone marrow sampling. They will complete questionnaires (oncogeriatric, comorbidity, fatigue/quality-of-life, and hemorrhagic assessments). Data and samples will be used to assess correlations between symptoms, exam findings, and hyperviscosity over a period of about 3 years.
How the study is structured. An interventional, non-randomized, open (no masking) study with parallel groups defined by presence or absence of hyperviscosity. Participants have fundus photographs sent for central review and provide additional blood and bone marrow samples for laboratory and molecular analyses. Data from questionnaires about bleeding, fatigue, comorbidities and quality of life will be compared with eye findings and lab results over the study period.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Waldenström macroglobulinemia
Important dates
- Study start
- May 14, 2021
- Primary completion
- August 2025 (estimated)
- Study completion
- August 2026 (estimated)
- Target enrollment
- 100 participants (estimated)
- Last updated on registry
- May 29, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Collaborators
- Centre Hospitalier Saint Vincent
- Centre Henri Becquerel
- University Hospital, Caen
- University Hospital, Lille
- Centre Hospitalier de Lens
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Magalie JORIS, MD 📞 03 22 45 54 19 ✉ joris.magalie@chu-amiens.fr
Participating sites (1)
- CHU AmiensRecruiting
Amiens, 80480 · France
- Magalie JORIS, MD · 03.22.45.54.19 · joris.magalie@chu-amiens.fr
- Fabrice JARDIN, MD
- Xavier TROUSSARD, MD
- Gandhi DAMAJ, MD
- Stéphanie POULAIN, MD
- Daniela ROBU, MD
Terms used on this page · explanations by MedicalUpdates.ai
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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