Back to resultsUtility of PCD Diagnostics to Improve Clinical Care
Primary Purpose
Primary Ciliary Dyskinesia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
nNO testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Primary Ciliary Dyskinesia
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
Sites / Locations
- Vanderbilt Children's hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Nasal Nitric Oxide testing and collection of clinical data
Arm Description
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
Outcomes
Primary Outcome Measures
frequency of nNO tests performed
number of tests
Frequency of genetic tests performed
number of tests
Secondary Outcome Measures
Full Information
NCT ID
NCT03704207
First Posted
October 8, 2018
Last Updated
November 16, 2022
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03704207
Brief Title
Utility of PCD Diagnostics to Improve Clinical Care
Official Title
Utility of PCD Diagnostics to Improve Clinical Care
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Ciliary Dyskinesia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nasal Nitric Oxide testing and collection of clinical data
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
nNO testing
Intervention Description
Collection of already performed clinical data and nNO testing
Primary Outcome Measure Information:
Title
frequency of nNO tests performed
Description
number of tests
Time Frame
3 years
Title
Frequency of genetic tests performed
Description
number of tests
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael O'Connor, MD
Phone
615.343.7617
Email
michael.g.oconnor@vumc.org
Facility Information:
Facility Name
Vanderbilt Children's hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael O'Connor, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Utility of PCD Diagnostics to Improve Clinical Care
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