CFTR Related Pancreatitis Study

The Hospital for Sick Children

Status: Withdrawn

Conditions: CFTR Gene Dysfunction; Cystic Fibrosis

Treatments: Combination Product: Beta Adrenergic Sweat Test

Study type: Interventional

Funder types: Other

Identifiers

NCT04274413

1000065960

Details and patient eligibility

About

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.

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age : 4 years and older

• Diagnosis: Acute recurrent pancreatitis or chronic pancreatitis

• History: at least one of the following:

  1. Carry one or two CFTR mutations

  2. Borderline sweat chloride levels

  3. Has Family History of CF

  4. Has had positive CF Newborn screening

     Exclusion Criteria:

• Pregnant females: will be excluded at screening.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Interventional Arm

Experimental group

Description:

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.

Treatment:

Combination Product: Beta Adrenergic Sweat Test