CFTR Related Pancreatitis Study

NCT04274413 | Withdrawn

• 1 other identifier: 1000065960
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cystic Fibrosis; CFTR Gene Dysfunction

Outcome Measures

Primary Outcomes (1)

• Assessment of CFTR function using the Beta Adrenergic Sweat Secretion Test

  CFTR function assessment of patients with acute recurrent or chronic pancreatitis by using Beta adrenergic sweat test.

  60 mins

Study Arms (1)

Interventional Arm

EXPERIMENTAL

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

Interventions

Beta Adrenergic Sweat Test COMBINATION_PRODUCT

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. 1. Two sensor probes will be strapped to the forearm with rubber bands in position just above the injection site. 2. Under the first probe, injection atropine will be given in one small area of the skin. 3. Under the second probe, first injection carbachol will be given in one small area of the skin. 4. Next, at the second probe area, the normal sweating will be stopped for awhile by injecting a drug called atropine. 5. 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.

Interventional Arm

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant females: will be excluded at screening.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• The National Pancreas Foundation: collaborator

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Senior Associate Scientist

Model Details: Evaporimeter TEWL probes, model RG-1

Study Record Dates

• First Submitted: February 16, 2020
• First Posted: February 18, 2020
• Study Start: February 1, 2021
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: July 16, 2021

Record last verified: 2021-07