RECRUITING

Sinus Disease in Young Children With Cystic Fibrosis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a prospective, observational study examining the impact of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators on chronic rhinosinusitis (CRS) and olfactory dysfunction (OD) in young children with cystic fibrosis (YCwCF). This study involves two groups: children 2-8 years old, inclusive at initial visit, receiving highly effective modulator therapy (HEMT), and a control group of children 2-8 years old, inclusive at initial visit, not receiving HEMT. Outcomes will include sinus magnetic resonance imaging (MRI) scans, olfactory tests, and quality of life surveys obtained over a two-year period.

Official Title

Sinus Disease in Young Children With Cystic Fibrosis

Quick Facts

Study Start:2023-04-12
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06191640

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 8 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Children with documentation of a CF diagnosis
  2. * Age 2-8 years old at first study visit
  3. * CFTR mutation consistent with FDA labeled indication of highly effective modulator therapy (ivacaftor or elexacaftor/tezacaftor/ivacaftor)
  4. * Clinician intent to prescribe ivacaftor or ETI so that enrollment is before start of HEMT
  5. * Children with documentation of a CF diagnosis
  6. * Age 2-8 years at first study visit
  7. * Ineligible for highly effective modulator therapy (ivacaftor or elexacaftor/tezacaftor/ivacaftor) based on CFTR mutation or clinical decision not to initiate HEMT if eligible
  1. * Use of an investigational drug within 28 days prior to the first study visit
  2. * Use of ivacaftor or elexacaftor/tezacaftor/ivacaftor within the 180 days prior to and including the first study visit
  3. * Use of chronic oral corticosteroids within the 28 days prior to and including the first study visit.
  4. * Sinus surgery within 180 days prior to the first study visit

Contacts and Locations

Study Contact

Daniel M Beswick, MD
CONTACT
310-206-8457
dbeswick@mednet.ucla.edu
Rhea Churi, BS
CONTACT
310-923-2534
rchuri@mednet.ucla.edu

Principal Investigator

Daniel M Beswick, MD
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles

Study Locations (Sites)

Children's Hospital Colorado
Aurora, Colorado, 80045
United States
University of Iowa
Iowa City, Iowa, 52242
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
United States
University of Vermont
Colchester, Vermont, 05446
United States
University of Virginia
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

  • Daniel M Beswick, MD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-12
Study Completion Date2026-04

Study Record Updates

Study Start Date2023-04-12
Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

  • Cystic Fibrosis
  • Chronic Rhinosinusitis
  • Olfactory Dysfunction

Additional Relevant MeSH Terms

  • Cystic Fibrosis in Children
  • Cystic Fibrosis
  • Chronic Rhinosinusitis (Diagnosis)
  • Olfactory Disorder
  • Olfactory Impairment