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Recruiting NCT03704207

Utility of PCD Diagnostics to Improve Clinical Care

No phase Interventional Primary Ciliary Dyskinesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: nNO testing.
Who it may be relevant to
Registry conditions: Primary Ciliary Dyskinesia. Basic parameters: from 1 year · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other nNO testing
    Collection of already performed clinical data and nNO testing

Primary outcome measures

  • frequency of nNO tests performed [Time frame: 3 years]
  • Frequency of genetic tests performed [Time frame: 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Vanderbilt Children's hospital — Nashville

Identifiers

NCT: NCT03704207 · IRB #160951

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗