CFTR Related Pancreatitis Study

Sponsor

The Hospital for Sick Children (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04274413

Collaborator

The National Pancreas Foundation (Other)

Enrollment

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis CFTR Gene Dysfunction	Combination Product: Beta Adrenergic Sweat Test	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Evaporimeter TEWL probes, model RG-1Evaporimeter TEWL probes, model RG-1

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Feb 1, 2021

Actual Primary Completion Date :

Feb 1, 2021

Actual Study Completion Date :

Feb 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Combination Product: Beta Adrenergic Sweat Test In Beta Sweat Test - sweat secretion will be stimulated by injecting a series of drugs within the skin surface. Small needles will be used to inject minute amounts of each drug. Before and after each skin injection, the skin will be cleaned using an alcohol swab. Two sensor probes will be strapped to the forearm with rubber bands in position just above the injection site. Under the first probe, injection atropine will be given in one small area of the skin. Under the second probe, first injection carbachol will be given in one small area of the skin. Next, at the second probe area, the normal sweating will be stopped for awhile by injecting a drug called atropine. Lastly, beta-adrenergic sweating will be stimulated by injecting a combination of the following drugs: atropine, isoproterenol, and aminophylline (β-cocktail). Using probes, all sweat rate readings will be recorded.

Arm

Intervention/Treatment

Experimental: 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.

Combination Product: Beta Adrenergic Sweat Test

In Beta Sweat Test - sweat secretion will be stimulated by injecting a series of drugs within the skin surface. Small needles will be used to inject minute amounts of each drug. Before and after each skin injection, the skin will be cleaned using an alcohol swab. Two sensor probes will be strapped to the forearm with rubber bands in position just above the injection site. Under the first probe, injection atropine will be given in one small area of the skin. Under the second probe, first injection carbachol will be given in one small area of the skin. Next, at the second probe area, the normal sweating will be stopped for awhile by injecting a drug called atropine. Lastly, beta-adrenergic sweating will be stimulated by injecting a combination of the following drugs: atropine, isoproterenol, and aminophylline (β-cocktail). Using probes, all sweat rate readings will be recorded.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant females: will be excluded at screening.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The Hospital for Sick Children
The National Pancreas Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tanja Gonska, Associate Professor and Senior Associate Scientist, The Hospital for Sick Children

ClinicalTrials.gov Identifier:

NCT04274413

Other Study ID Numbers:

1000065960

First Posted:

Feb 18, 2020

Last Update Posted:

Jul 16, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Cystic Fibrosis

Pancreatitis

Adrenergic Agents

Study Results

No Results Posted as of Jul 16, 2021