NL-OMON49034已完成不适用
I-BALL 2: Non-invasive Disease Monitoring in Infants with Cystic Fibrosis - I-BALL 2 study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •Subjects are eligible for this study when they are:
- •Diagnosed with CF, either by abnormal sweat test and/or confirmed with 2
- •mutations found by genetic analysis, either from heel-prick screening or
- •diagnosed later in life.
- •Aged 1, 3 or 5 years, when they undergo bronchoscopy and chest CT scan as
- •part of the routine monitoring program for CF.
- •Aged 1, 2, 3, 4, or 5 years, when they visit the outpatient clinic for
- •routine yearly follow-up, the patient will be eligible for induced Sputum,
- •exhaled breath collection and blood collection for TiMaSCAN.
- •Authorized by a written informed consent from parents to undergo a sputum
- •induction to collect Induced Sputum (IS), to collect exhaled breath for
- •Volatile Organic Compounds (VOC) analysis, to collect an extra vial of blood
- •during the routine venous puncture, a nasopharyngeal swab (during anesthesia
- •when applicable) and permission to use excess biomaterials, especially BALF
- •retrieved during bronchoscopy and coded clinical data for research. Parents
- •may choose to opt in or out for separate parts of the study.
排除标准
- •Absence of previously given informed consent for use of encoded clinical data
- •for scientific purposes.
研究者
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