Iceland Screens, Treats or Prevents Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80,761
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This study will assess the benefits and harms of screening for monoclonal gammopathy of undetermined significance (MGUS). The overall and disease-specific mortality will be compared between screened and not screened participants. All individuals registered as inhabitants in Iceland and born in 1975 or earlier have been invited to participate. The hypothesis is that an early detection of multiple myeloma (MM), through follow-up of MGUS, will improve overall survival and decrease complications associated with diagnosis and treatment of MM.
详细描述
Monoclonal gammopathy of undetermined significance (MGUS) is an asymptomatic premalignant stage that almost always precedes multiple myeloma (MM) and amyloidosis. It is defined by a monoclonal-(M)-protein detected on serum protein electrophoresis or immunofixation electrophoresis and can be diagnosed with a blood sample. Approximately four percent of individuals 50 years or older have MGUS which is associated with a 1-2% annual risk of malignant transformation but it is impossible to predict which individuals diagnosed as having MGUS will progress and receive a diagnosis of malignant disease.
To date, no evidence is available on the benefits and harms of population-based screening for MGUS and data from prospective studies that assess the optimal follow-up of MGUS are lacking.
All individuals that are registered as inhabitants in Iceland and born in 1975 or earlier have been invited to participate in the study. After signing informed consent, serum from the participants will be analysed for MGUS. The participants will not be contacted for blood sampling. Instead, an innovative approach will be used by taking advantage of the fact that most people 40 years or older do a blood test for various reasons during a three year period. The ID-list of participants in the study will be cross-linked with all major laboratories in Iceland, covering approximately 90% of all blood sampling in Iceland. When a participant has a blood test, a small amount (1 ml) of serum will be sampled and put in a separate test tube belonging to the study and used for diagnosis of MGUS.
Participants diagnosed as having MGUS will be randomized to three different arms, of which two arms will be called into a clinical study center for two separate types of follow-up. In arm one the participants will be asked to answer an electronic Mental Health and Quality of Life questionnaire annually but receive no active follow-up. In arm two and three the participants will be asked to answer the Mental Health and QoL questionnaire but also receive follow-up according to the International Myeloma Working Group (IMWG) guidelines (arm two) or intensive (arm three) clinical follow-up. Participants without MGUS will be asked to answer Mental Health and QoL questionnaire annually.
Results from two recent, population-based studies shows that early detection of MM through follow-up of MGUS is associated with fewer major complications and 13-14% better overall survival as compared to individuals presenting with MM without previous diagnosis of MGUS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Investigators and participants will be blinded to what participants are in the normal group and which participants are in arm 1 in the MGUS-group.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Born 1975 or earlier
- •With registered address in Iceland on November 1st 2016
排除标准
- •Prior multiple myeloma
- •Lymphoproliferative disease
- •Amyloidosis
- •M-protein >30 g/L or involved:uninvolved serum FLC ratio >100
- •Individuals with prior history of MGUS will be offered to be randomized into either moderate or intensive clinical follow-up (arms 2 or 3).
结局指标
主要结局
Overall survival
时间窗: 5 years from study start.
Number of participants alive in each study arm
次要结局
- Cause specific survival(5 years from study start)
- Cost-effectiveness of screening for MGUS(5 years from study start)
- Global satisfaction with one´s life as assessed by the Satisfaction with life (SWLS)(5 years from study start.)
- Happiness as assessed by the Single item measure for happiness(5 years from study start)
- Resilience as assessed by The Connor-Davidson resilience scale (CD-RISC)(5 years from study start)
- Social support as assessed by the Multidimensional scale of perceived social support (MSPSS)(5 years from study start)
- Adverse childhood experiences as assessed by the Adverse childhood experiences international questionnaire (ACE-IQ)(5 years from study start)
- Depressive symptoms as assessed by the Patient health questionnaire (PHQ-9)(5 years from study start)
- Anxiety symptoms as assessed by the Generalized anxiety disorder (GAD-7)(5 years from study start)
- Worry as assessed by the Single item measure for worry(5 years from study start)
- Stress as assessed by the Perceived stress scale (PSS-10)(5 years from study start)
- Post-traumatic stress symptoms as assessed by the Posttraumatic stress disorder checklist for DMS-5 (PCL-5) including the Life Events Checklist for DSM-5 (LEC-5)(5 years from study start)
- Health as assessed by the 36-Item short form survey (SF-36)(5 years from study start)