The Alpha-1 Foundation's and University of Florida's Alpha-1 Coded Testing (ACT) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50,000
- 试验地点
- 1
- 主要终点
- Structured questionnaire responses on the risks and benefits of testing.
研究概览
简要总结
The Alpha-1 Coded Testing (ACT) Study was established to study genetic testing and outcomes of individuals at risk for alpha-1 antitrypsin deficiency.
详细描述
Genetic testing for alpha-1 antitrypsin deficiency is sometimes delayed despite established testing indications. All genetic tests have risks and possible benefits. The ACT study evaluates the population demographics, reasons for testing, and outcomes through a confidential testing program. Co-morbidities of alpha-1 antitrypsin deficiency other than lung and liver disease are being investigated. Concerns about genetic confidentiality are lessened in this study by a coded testing procedure that returns results through the mail to study participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals of any age at risk for alpha-1 antitrypsin deficiency on the basis of symptoms or family genetic risk.
排除标准
- •Any person who has already had genotype and AAT level testing completed and has a qualified result.
结局指标
主要结局
Structured questionnaire responses on the risks and benefits of testing.
时间窗: Before and after alpha-1 antitrypsin testing
Rotating questionnaires assess the clinical course and co-morbidities associated with different genotypes of alpha-1 antitrypsin deficiency.
次要结局
未报告次要终点