跳至主要内容
临床试验/NCT04274413
NCT04274413撤回不适用

Assessing CFTR Function in Patients With CFTR Related Pancreatitis Using a Novel Sweat Test

The Hospital for Sick Children0 个研究点开始时间: 2021年2月1日最近更新:
适应症

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

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.

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tanja Gonska

Associate Professor and Senior Associate Scientist

The Hospital for Sick Children

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