The Ear-Nose-Throat (ENT) Prospective International Cohort of PCD Patients (EPIC-PCD)
NCT ID: NCT04611516
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
1000 participants
OBSERVATIONAL
2020-03-02
2040-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
International Primary Ciliary Dyskinesia (PCD) Registry
NCT02419365
Registry for Primary Ciliary Dyskinesia
NCT03271840
A Natural History Study of Infantile Neuroaxonal Dystrophy
NCT04027816
Craniofacial Microsomia: Accelerating Understanding of the Significance and Etiology
NCT04351893
European Paediatric AFM Associated With EV-D68 Follow-up Study.
NCT03499366
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The investigators aim to:
1. Assess the prevalence and severity of sinonasal and otologic symptoms and the frequency and range of signs and physiological findings assessed during standardised ENT physical examination, and describe differences by age;
2. Study the association of sinonasal and otologic disease with lower respiratory disease in PCD patients;
3. Identify determinants of disease course and prognosis of sinonasal and otologic disease in PCD patients
4. Study management practices and identify determinants that inform them.
Study design:
The EPIC-PCD is a prospective observational clinical cohort study, set up as a multinational multi-centre study. It is embedded into routine patient care of participating reference centres for PCD and patients will keep being managed according to local procedures and guidelines.
Patients with PCD are followed regularly at each centre, at 3-month to 6-month intervals. Each patient undergoes a detailed ENT sinonasal and otologic examination by ENT specialists, at minimum once a year, during a programmed follow-up visit. Additional ENT examinations are performed if indicated during in-between follow-up visits. Patients will not be subjected to additional invasive measurements solely for the purposes of the study.
What information is collected:
The study collect clinical data from patients assessment at regular consultations at the outpatient clinics.
For the collection of clinical data, participating centres will use FOLLOW-PCD, a disease-specific form for standardised prospective data collection during routine clinical follow-up of PCD patients.
Study database:
The EPIC-PCD database is web-based, using the Research Electronic Data Capture (REDCap) platform developed at Vanderbilt University. REDCap is widely used in academic research and allows data entry and extraction in various formats.
How to participate:
Centres that wish to participate to the project and contribute data can contact the EPIC-PCD managing centre to sign a data delivery agreement. They then will receive a password to access the online software REDCap and they will be able to enter their data directly. They can also upload follow-up data or add additional patients at a later time point.
Funding:
The setting up of the EPIC-PCD (salaries, consumables and equipment) was funded by the Swiss National Science Foundation. Data collection and management at each site was funded according to local arrangements. Most participating researchers and data contributors participate in the European Respiratory Society Clinical Research collaboration "Better Evidence to Advance Therapeutic options for PCD" (BEAT-PCD) (https://beat-pcd.squarespace.com/). Infrastructure is provided for free by the University of Bern, where the data are pooled and stored.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient must undergo an ENT examination minimum once a year as part of their clinical follow-up
Exclusion Criteria
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bicetre Hospital
OTHER
Centre Hospitalier Intercommunal Creteil
OTHER
University Hospital Southampton NHS Foundation Trust
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
Amsterdam UMC, location VUmc
OTHER
University of Cyprus
OTHER
Hacettepe University
OTHER
Marmara University
OTHER
Hospital Universitario La Fe
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
University of Bern
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Myrofora Goutaki, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
University of Bern
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Bern
Bern, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Goutaki M, Lam YT, Alexandru M, Anagiotos A, Armengot M, Bequignon E, Boon M, Burgess A, Coste A, Emiralioglu N, Erdem E, Haarman EG, Harris A, Hool SL, Karadag B, Kim S, Latzin P, Lorent N, Ozcelik U, Reula A, Roehmel J, van Gogh C, Yiallouros P, Zappe SM; EPIC-PCD team; Papon JF. Study protocol: the ear-nose-throat (ENT) prospective international cohort of patients with primary ciliary dyskinesia (EPIC-PCD). BMJ Open. 2021 Oct 11;11(10):e051433. doi: 10.1136/bmjopen-2021-051433.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EPIC-PCD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.