Hyperviscosity SyndromeSLPRaresHviscNCT04898647
Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia
A study testing fundoscopic picture, blood sample and bone marrow sample in people with Hyperviscosity Syndrome and Waldenstrom Macroglobulinemia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperviscosity Syndrome, Waldenstrom Macroglobulinemia
- What is being tested?
- fundoscopic picture, blood sample and bone marrow sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 14 May 2021to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80480
Magalie JORIS, MD, 03.22.45.54.19, joris.magalie@chu-amiens.fr
Fabrice JARDIN, MD
About this study
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.
- Being tested
- fundoscopic picture, blood sample, bone marrow sample
- Keywords
- Hyperviscosity Syndrome, Waldenstrom Macroglobulinemia
- Medical subject headings
- Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fundoscopic pictureOther
A central review of numerised fundoscopic picture will be performed.
blood sampleBiological
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 sampleProcedure or surgery
Five to 10 ml bone marrow sample will be collected in addition to standard bone marrow sampling for getting molecular characteristics of WM
| Study group | Role | What they receive |
|---|---|---|
| Patients with confirmed HVS | Experimental | presence of unexplained elsewhere fundoscopic abnormalities AND either IgM concentration above 30 g/L (densitometry) or cryoglobulin activity Receives: Other: fundoscopic picture; Biological: blood sample; Procedure: bone marrow sample |
| Patients with confirmed absence of HVS | Active comparator | Not described Receives: Other: fundoscopic picture; Biological: blood sample; Procedure: bone marrow sample |
| Remaining patients | Experimental | Not described Receives: Other: fundoscopic picture; Biological: blood sample; Procedure: bone marrow sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Correlation between fundoscopic findings and HVS detection
Correlation between fundoscopic findings and HVS detection
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start14 May 2021
- Primary completionAug 2025 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperviscosity SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Saint Vincent, Centre Henri Becquerel, University Hospital, Caen, University Hospital, Lille, Centre Hospitalier de Lens
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898647
- Sponsor's protocol ID
- PI2020_843_0109
- Acronym
- SLPRaresHvisc
- Status last verified
- May 2025
- First submitted
- 17 May 2021
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia
- ClinicalTrials.gov ID
- NCT04898647
- Acronym / sponsor ID
- SLPRaresHvisc / PI2020_843_0109
- Keywords
- Hyperviscosity Syndrome, Waldenstrom Macroglobulinemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Centre Hospitalier Saint Vincent, Centre Henri Becquerel, University Hospital, Caen, University Hospital, Lille, Centre Hospitalier de Lens
- Study start
- 14 May 2021 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with confirmed HVS | Experimental | Other: fundoscopic picture, Biological: blood sample, Procedure: bone marrow samplepresence of unexplained elsewhere fundoscopic abnormalities AND either IgM concentration above 30 g/L (densitometry) or cryoglobulin activity |
| Patients with confirmed absence of HVS | Active comparator | Other: fundoscopic picture, Biological: blood sample, Procedure: bone marrow sample |
| Remaining patients | Experimental | Other: fundoscopic picture, Biological: blood sample, Procedure: bone marrow sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fundoscopic pictureA central review of numerised fundoscopic picture will be performed. | Other | Patients with confirmed HVS, Patients with confirmed absence of HVS, Remaining patients |
| blood sampleTwo 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 | Biological | Patients with confirmed HVS, Patients with confirmed absence of HVS, Remaining patients |
| bone marrow sampleFive to 10 ml bone marrow sample will be collected in addition to standard bone marrow sampling for getting molecular characteristics of WM | Procedure or surgery | Patients with confirmed HVS, Patients with confirmed absence of HVS, Remaining patients |
Primary outcome
Correlation between items collected in questionnaires and HVS detection
Time frame: 3 years
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.
Correlation between fundoscopic findings and HVS detection
Time frame: 3 years
Correlation between fundoscopic findings and HVS detection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fundoscopic picture, blood sample and bone marrow sample in people with Hyperviscosity Syndrome and Waldenstrom Macroglobulinemia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magalie JORIS, MD (03 22 45 54 19, joris.magalie@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between items collected in questionnaires and HVS detection (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.