Utility of PCD Diagnostics to Improve Clinical Care

Not Applicable

Recruiting

• Conditions: Primary Ciliary Dyskinesia

• Registration Number: NCT03704207
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

This is a study evaluating the utility of current Primary Ciliary Dyskinesia (PCD) diagnostic tests, including nasal nitric oxide testing.

Detailed Description

This study is a prospective data collection of individuals referred to the investigators clinical center for considerations of PCD. Participants sign informed consent to have clinical information entered into a secure electronic database. As part of this study, participants may have nasal nitric oxide (nNO) testing performed. nNO testing is a research procedure, but it is a test with growing utility for making a diagnosis of PCD when performed in the right clinical setting.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-11
• Study First Posted: 2018-10-12
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-28
• Last Update Posted: 2025-07-01
• Primary Completion: 2028-06-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Referred to center for PCD diagnosis considerations
• Ability to perform study procedures
• Age greater than 2 years of age

Exclusion Criteria

• Age less than 2 years of age Inability to perform informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
frequency of nNO tests performed	3 years	number of tests
Frequency of genetic tests performed	3 years	number of tests

Trial Locations

Locations (1)

Vanderbilt Children's hospital; 🇺🇸 Nashville, Tennessee, United States