Utility of PCD Diagnostics to Improve Clinical Care
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 →
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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