Utility of PCD Diagnostics to Improve Clinical Care

• Sponsor: Vanderbilt University Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03704207
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 96
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Primary Ciliary Dyskinesia	Other: nNO testing	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Utility of PCD Diagnostics to Improve Clinical Care
• Actual Study Start Date: Jun 1, 2017
• Anticipated Primary Completion Date: Jun 1, 2025
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

Arm

Intervention/Treatment

Other: Nasal Nitric Oxide testing and collection of clinical data 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

Other: nNO testing; Collection of already performed clinical data and nNO testing

Outcome Measures

Primary Outcome Measures

1. frequency of nNO tests performed [3 years]

   number of tests

2. Frequency of genetic tests performed [3 years]

   number of tests

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt Children's hospital	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

• Vanderbilt University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael O'Connor, Assistant Professor, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT03704207
• Other Study ID Numbers: IRB #160951
• First Posted: Oct 12, 2018
• Last Update Posted: Oct 12, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ciliary Motility Disorders; Dyskinesias

Study Results

No Results Posted as of Oct 12, 2021