RECRUITING

Utility of PCD Diagnostics to Improve Clinical Care

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This cross-sectional and longitudinal observational study is to gather data on the utility of tests that are used to make a diagnosis of primary ciliary dyskinesia (PCD). There is new testing available, called nasal nitric oxide testing, that non-invasively measures nitric oxide levels in the sinus cavity. Individuals with PCD characteristically have low levels, but this testing does not have extensive data from everyday clinical practice. The objective of this proposal is to improve the diagnostic approach to children and adults with clinical concerns for primary ciliary dyskinesia (PCD).

Official Title

A Clinical Study to Gather Data on the Utility of Tests That Are Used to Make a Diagnosis of Primary Ciliary Dyskinesia (PCD)

Quick Facts

Study Start:2023-10-17
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05889013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 2 years of age
  2. * Must have two of the following clinical history points:
  3. * Neonatal respiratory distress
  4. * Chronic nasal congestion/runny nose
  5. * Chronic cough
  6. * Situs/laterality defects
  7. * Bronchiectasis
  8. * Ability to provide informed consent or consent of parent/guardian and ass
  1. * Recent history of sinus surgery or bloody nose in the past week
  2. * Age \< 2 years of age
  3. * Inability to tolerate probe in nose
  4. * Sinusitis or other respiratory exacerbation currently being treated with antibiotics
  5. * Admitted to hospital for respiratory exacerbation (inpatient status)
  6. * Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by the IRB)
  7. * Any other reason for which the study investigators feel the patient is not a good candidate to complete the testing

Contacts and Locations

Study Contact

Melanie S Collins, MD
CONTACT
860-545-9440
mcollin@connecticutchildrens.org
Sigrid M Almeida, BS
CONTACT
8608375343
salmeida@connecticutchildrens.org

Principal Investigator

Melanie S Collins, MD
PRINCIPAL_INVESTIGATOR
Connecticut Children's Medical Center

Study Locations (Sites)

Pulmonary Division
Hartford, Connecticut, 06111
United States

Collaborators and Investigators

Sponsor: Connecticut Children's Medical Center

  • Melanie S Collins, MD, PRINCIPAL_INVESTIGATOR, Connecticut Children's Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-17
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-10-17
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • PCD
  • nasal nitric oxide testing

Additional Relevant MeSH Terms

  • Primary Ciliary Dyskinesia