Understanding Monoclonal Gammopathy of Unknown Significance (MGUS): A Research Study to Investigate the Functional Consequences of Paraprotein Production in MGUS
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 664
- 试验地点
- 9
- 主要终点
- Clinical assays (i.e. Haematology, biochemistry, immunology, endocrinology): to capture the number of assay phenotypes that are statistically different from normal ranges.
研究概览
简要总结
This is a study to investigate the functional consequences of paraprotein production in MGUS (Monoclonal Gammopathy of Unknown Significance).
详细描述
Monoclonal gammopathy of unknown significance (MGUS) is a common haematological condition. It is characterised by proliferation of a B lymphocyte clone and it's associated antibody (paraprotein). In most cases there are no clinical symptoms, however, in a small number of individuals there may be an interaction of the paraprotein with a molecule expressed by the body (self antigen). This can have effects on the normal function of this molecule and/or cause disease.
The study aims to investigate the functional consequences of paraprotein production in MGUS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Participants must comply with the following criteria in order to be eligible for the study:
- •Be aged ≥18 years at the time the informed consent form is signed
- •Have a confirmed and documented Monoclonal Gammopathy of Unknown Significance (MGUS) diagnosis
- •Read and understood the participant information sheet, and signed an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved informed consent form prior to any study- specific evaluation
排除标准
- •Participants will be excluded from joining the study if they match any of the criteria below:
- •Pre-existing diagnosis of myeloma/lymphoma
- •Participation in a therapeutic clinical study within 28 days or (5 half lives, whichever is longer) of enrolment or during this study
- •Any other reason the Clinical Investigator (CI) considers the participant should not join the study
结局指标
主要结局
Clinical assays (i.e. Haematology, biochemistry, immunology, endocrinology): to capture the number of assay phenotypes that are statistically different from normal ranges.
时间窗: Up to 4 years from study start
For clinical assays with defined normal ranges, we will capture those results that are significantly outside of normal range. For those with no generally accepted normal ranges, the results will be compared against results from the other individuals.
次要结局
- The number of conversions to multiple myeloma(2 years after the first visit)