Assessing CFTR Function in Patients With CFTR Related Pancreatitis Using a Novel Sweat Test
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Assessment of CFTR function using the Beta Adrenergic Sweat Secretion Test
研究概览
简要总结
The main causes of acute recurrent pancreatitis (ARP) or chronic pancreatitis (CP) in children are defects in genes that have been associated to pancreatitis. Among these gene defects CFTR gene mutations are commonly found, 34% ARP and 23% CP . Since not every CFTR gene mutations clinically manifest, just identifying these CFTR gene mutations may not help to establish a clear role of this defect in the etiology of the individual ARP/CP. The novel beta-adrenergic sweat secretion test is a very sensitive test to detect small abnormalities in CFTR function in form of a linear gene-function relation. By identifying even mild CFTR defects, in future will help in finding the role of CFTR modulators and providing treatment to these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : 4 years and older
- •Diagnosis: Acute recurrent pancreatitis or chronic pancreatitis
- •History: at least one of the following:
- •Carry one or two CFTR mutations
- •Borderline sweat chloride levels
- •Has Family History of CF
- •Has had positive CF Newborn screening
排除标准
- •Pregnant females: will be excluded at screening.
研究组 & 干预措施
Interventional Arm
All patients consented to study will undergo study intervention which is Beta-adrenergic sweat test (Beta sweat test) using evaporimeter. It takes about 60 minutes to complete this test. Once this test is completed, patient will be considered to have completed the study.
干预措施: Beta Adrenergic Sweat Test (Combination Product)
结局指标
主要结局
Assessment of CFTR function using the Beta Adrenergic Sweat Secretion Test
时间窗: 60 mins
CFTR function assessment of patients with acute recurrent or chronic pancreatitis by using Beta adrenergic sweat test.
次要结局
未报告次要终点
研究者
Tanja Gonska
Associate Professor and Senior Associate Scientist
The Hospital for Sick Children