Study protocol: the ear-nose-throat (ENT) prospective international cohort of patients with primary ciliary dyskinesia (EPIC-PCD).
Myrofora Goutaki, Yin Ting Lam, Mihaela Alexandru...
https://pubmed.ncbi.nlm.nih.gov/34635525Actively Recruiting
All Genders
ID04611516
The Ear-Nose-Throat (ENT) Prospective International Cohort of PCD Patients (EPIC-PCD)
Led by University of Bern · Updated on 2025-12-02
1000
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
Sponsors
U
University of Bern
Lead Sponsor
B
Bicetre Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The EPIC-PCD is a multinational, prospective observational clinical cohort study focused on patients with Primary Ciliary Dyskinesia (PCD). It investigates ear, nose, and throat (ENT) disease in PCD patients, studying its connection to lower respiratory disease and identifying factors that influence disease prognosis. The study is integrated into routine care at participating reference centers and follows patients based on local guidelines. Patients with PCD are regularly followed every 3 to 6 months at outpatient clinics, with detailed ENT sinonasal and otologic examinations performed at least once a year by specialists. Additional ENT check-ups occur as needed during routine visits. No extra invasive procedures are done solely for the study. Data collection uses a standardized form called FOLLOW-PCD and is entered into a secure web-based database system called REDCap. Participants are involved through their regular clinical visits, where clinical data are collected without additional procedures beyond standard care. Researchers assess symptoms and signs related to sinonasal and otologic health, using tools such as nasal endoscopy, ear examinations, tympanometry, and audiometry at baseline and at yearly intervals up to two years. The study aims to better understand the course and management of ENT disease in PCD patients over time.
CONDITIONS
Brief Title
The Ear-Nose-Throat (ENT) Prospective International Cohort of PCD Patients (EPIC-PCD)
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of Primary Ciliary Dyskinesia (PCD) confirmed by clinical and test criteria
- Patient must undergo an ear, nose, and throat (ENT) examination at least once a year as part of clinical follow-up
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Long-term Monitoring
Duration - Up to several years according to routine clinical follow-up
Participants are followed regularly during routine clinical care to assess sinonasal and otologic symptoms through detailed ENT examinations.
Visits every 3 to 6 months with at least 1 detailed ENT examination annually
Trial Site Locations
Total: 1 location
1
University of Bern
Bern, Switzerland
Actively Recruiting
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Research Team
M
Myrofora Goutaki, MD-PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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