CFTR Related Pancreatitis Study

Not Applicable

Withdrawn

• Conditions: CFTR Gene Dysfunction; Cystic Fibrosis
• Interventions: Combination Product: Beta Adrenergic Sweat Test

• Registration Number: NCT04274413
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-16
• Study First Submitted QC: 2020-02-16
• Study First Posted: 2020-02-18
• Study Start: 2021-02-01
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-12
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional Arm	Beta Adrenergic Sweat Test	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.

Primary Outcome Measures

Name	Time	Method
Assessment of CFTR function using the Beta Adrenergic Sweat Secretion Test	60 mins	CFTR function assessment of patients with acute recurrent or chronic pancreatitis by using Beta adrenergic sweat test.