Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Correlation between fundoscopic findings and HVS detection
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients with confirmed HVS
presence of unexplained elsewhere fundoscopic abnormalities AND either IgM concentration above 30 g/L (densitometry) or cryoglobulin activity
干预措施: fundoscopic picture (Other)
Patients with confirmed HVS
presence of unexplained elsewhere fundoscopic abnormalities AND either IgM concentration above 30 g/L (densitometry) or cryoglobulin activity
干预措施: blood sample (Biological)
Patients with confirmed HVS
presence of unexplained elsewhere fundoscopic abnormalities AND either IgM concentration above 30 g/L (densitometry) or cryoglobulin activity
干预措施: bone marrow sample (Procedure)
Patients with confirmed absence of HVS
干预措施: fundoscopic picture (Other)
Patients with confirmed absence of HVS
干预措施: blood sample (Biological)
Patients with confirmed absence of HVS
干预措施: bone marrow sample (Procedure)
Remaining patients
干预措施: fundoscopic picture (Other)
Remaining patients
干预措施: blood sample (Biological)
Remaining patients
干预措施: bone marrow sample (Procedure)
结局指标
主要结局
Correlation between fundoscopic findings and HVS detection
时间窗: 3 years
Correlation between fundoscopic findings and HVS detection
Correlation between items collected in questionnaires and HVS detection
时间窗: 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.
次要结局
未报告次要终点