NCT03855878已完成不适用
Prospective Observation of the Incidence and Natural History of Monoclonal Gammopathy in Patients Undergoing Weight Reduction Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 1
- 主要终点
- Rate of MGUS
研究概览
简要总结
Screening study to determine incidence of MGUS in this patient population
详细描述
This study is designed to observe the incidence of monoclonal gammopathy of undetermined significance (MGUS) among obese patients planning to have weight reduction surgery or planning to enter into a physician monitored weight loss program and to follow the regression or progression of MGUS following surgery or the initiation of the weight loss program.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients 30 years or older planning to undergo weight reduction surgery or planning to enter into a physician monitored weight loss program
- •Patients must be obese, defined as a BMI ≥ 30 as calculated by the formula:
- •weight in pounds / height squared x 703 = BMI
- •Subject consent and authorization for the release of health information must be obtained according to local institutional guidelines.
- •To remain in the study for the follow-up phase, the baseline screening test must indicate that a patient has MGUS.
排除标准
- •No history of any malignancy except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years.
- •No concurrent or planned participation in randomized trials of weight loss.
- •A patient will be excluded from the follow-up phase if the baseline screening test indicates they do not have MGUS
结局指标
主要结局
Rate of MGUS
时间窗: 5 years
The primary analysis focuses on the estimation of the rate of MGUS for this specific population.
次要结局
未报告次要终点
研究者
Rafat Abonour
Professor of Medicine
Indiana University
研究点 (1)
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