Utility of PCD Diagnostics to Improve Clinical Care

Not Applicable

Recruiting

• Conditions: Primary Ciliary Dyskinesia
• Interventions: Other: nNO testing

• 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-06
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nasal Nitric Oxide testing and collection of clinical data	nNO testing	Participants will have nNO testing is indicated. All participants in this study have some basic clinical data collected at time of enrollment. Participants with a confirmed diagnosis of PCD or in those participants with a working diagnosis of PCD in which ongoing nNO testing is performed have prospective data collection. Some participants have a confirmed diagnosis of PCD by genetics or ciliary biopsy at time of study entry and thus do not need nNO testing, but are followed prospectively with collection of basic clinical data

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