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The Ear-Nose-Throat (ENT) Prospective International Cohort of PCD Patients (EPIC-PCD) (EPIC-PCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04611516
Recruitment Status : Recruiting
First Posted : November 2, 2020
Last Update Posted : November 2, 2020
Sponsor:
Collaborators:
Bicetre Hospital
Centre Hospitalier Intercommunal Creteil
University Hospital Southampton NHS Foundation Trust
Universitaire Ziekenhuizen Leuven
VU University Medical Center
University of Cyprus
Hacettepe University
Marmara University
Hospital Universitario La Fe
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
University of Bern

Brief Summary:
The Ear-Nose-Throat (ENT) Prospective International Cohort of patients with Primary Ciliary Dyskinesia (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 keep being managed according to local procedures and guidelines.

Condition or disease
Primary Ciliary Dyskinesia Kartagener Syndrome

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Ear-Nose-Throat (ENT) Prospective International Cohort of PCD Patients (EPIC-PCD)
Actual Study Start Date : March 2, 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2030





Primary Outcome Measures :
  1. Sinonasal symptoms and signs [ Time Frame: at baseline ]
    Prevalence of reported clinical symptoms at different age groups, including rhinitis, sinusitis, snoring

  2. Course of sinonasal symptoms and signs (year 1) [ Time Frame: at 12 months from recruitment ]
    Change from baseline prevalence of reported clinical symptoms at different age groups, including rhinitis, sinusitis, snoring, at 12 months

  3. Course of sinonasal symptoms and signs (year 2) [ Time Frame: at 24 months from recruitment ]
    Change from baseline prevalence of reported clinical symptoms at different age groups, including rhinitis, sinusitis, snoring, at 24 months

  4. Otological symptoms and signs [ Time Frame: at baseline ]
    Prevalence of reported clinical symptoms at different age groups, including ear pain, hearing problems, ear discharge

  5. Course of otological symptoms and signs (year 1) [ Time Frame: at 12 months from recruitment ]
    Change from baseline prevalence of reported clinical symptoms at different age groups, including ear pain, hearing problems, ear discharge, at 12 months

  6. Course of otological symptoms and signs (year 2) [ Time Frame: at 24 months from recruitment ]
    Change from baseline prevalence of reported clinical symptoms at different age groups, including ear pain, hearing problems, ear discharge, at 24 months

  7. Nasal endoscopy (description of nasal mucosa) [ Time Frame: at baseline ]
    Description of nasal mucosa as seen via nasal endoscopy examination

  8. Nasal endoscopy (changes of nasal mucosa at year 1) [ Time Frame: at 12 months from recruitment ]
    Changes in nasal mucosa from baseline as seen via nasal endoscopy examination at 12 months

  9. Nasal endoscopy (changes of nasal mucosa at year 2) [ Time Frame: at 24 months from recruitment ]
    Changes in nasal mucosa from baseline as seen via nasal endoscopy examination at 24 months

  10. Nasal endoscopy (nasal polyps) [ Time Frame: at baseline ]
    Prevalence of nasal polyps at baseline

  11. Nasal endoscopy (nasal polyps at year 1) [ Time Frame: at 12 months from recruitment ]
    Changes in prevalence of nasal polyps from baseline to 12 months

  12. Nasal endoscopy (nasal polyps at year 2) [ Time Frame: at 24 months from recruitment ]
    Changes in prevalence of nasal polyps from baseline to 24 months

  13. Sinonasal examination (Lidholdt score) [ Time Frame: at baseline ]
    Lidholdt score at baseline

  14. Sinonasal examination (Lidholdt score at year 1) [ Time Frame: at 12 months from recruitment ]
    Changes in Lidholdt score from baseline to 12 months

  15. Sinonasal examination (Lidholdt score at year 2) [ Time Frame: at 24 months from recruitment ]
    Changes in Lidholdt score from baseline to 24 months

  16. Ear examination (ear discharge) [ Time Frame: at baseline ]
    Prevalence of ear discharge at baseline

  17. Ear examination (ear discharge at year 1) [ Time Frame: at 12 months from recruitment ]
    Changes in prevalence of ear discharge from baseline to 12 months

  18. Ear examination (ear discharge at year 2) [ Time Frame: at 24 months from recruitment ]
    Changes in prevalence of ear discharge from baseline to 24 months

  19. Otoscopy (description of the tympanic membrane) [ Time Frame: at baseline ]
    Description of tympanic membrane as seen via otoscopy examination

  20. Otoscopy (description of the tympanic membrane at year 1) [ Time Frame: at 12 months from recruitment ]
    Changes in the tympanic membrane from baseline to 12 months as seen via otoscopy examination

  21. Otoscopy (description of the tympanic membrane at year 2) [ Time Frame: at 24 months from recruitment ]
    Changes in the tympanic membrane from baseline to 24 months as seen via otoscopy examination

  22. Tympanometry [ Time Frame: at baseline ]
    Results of tympanometry (tympanogram type for both ears) at baseline

  23. Tympanometry (at year 1) [ Time Frame: at 12 months from recruitment ]
    Changes in tympanogram (for both ears) from baseline to 12 months

  24. Tympanometry (at year 2) [ Time Frame: at 24 months from recruitment ]
    Changes in tympanogram (for both ears) from baseline to 24 months

  25. Audiometry [ Time Frame: at baseline ]
    Results of audiometry: type of audiometry and results based on WHO hearing loss grades (for both ears)

  26. Audiometry (at year 1) [ Time Frame: at 12 months from recruitment ]
    Changes in audiometry results from baseline to 12 months

  27. Audiometry (at year 2) [ Time Frame: at 24 months from recruitment ]
    Changes in audiometry results from baseline to 24 months



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of all ages diagnosed with PCD, followed in a collaborating PCD centre
Criteria

Inclusion Criteria:

  • Diagnosis of PCD (clinical and test certified)
  • Patient must undergo an ENT examination minimum once a year as part of their clinical follow-up

Exclusion Criteria:

None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04611516


Contacts
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Contact: Myrofora Goutaki, MD-PhD 0041 316315973 myrofora.goutaki@ispm.unibe.ch
Contact: Yin Ting Lam, MD 0041 316315973 yin.lam@ispm.unibe.ch

Locations
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Switzerland
University of Bern Recruiting
Bern, Switzerland
Contact: Yin Ting Lam, MD       yin.lam@ispm.unibe.ch   
Sponsors and Collaborators
University of Bern
Bicetre Hospital
Centre Hospitalier Intercommunal Creteil
University Hospital Southampton NHS Foundation Trust
Universitaire Ziekenhuizen Leuven
VU University Medical Center
University of Cyprus
Hacettepe University
Marmara University
Hospital Universitario La Fe
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Myrofora Goutaki, MD-PhD University of Bern
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT04611516    
Other Study ID Numbers: EPIC-PCD
First Posted: November 2, 2020    Key Record Dates
Last Update Posted: November 2, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Not all participating centres have ethical approval to share IPD to external researchers.

Researchers wanting to use the dataset can propose a research topic and draft a concept sheet describing the planned analyses and publication. All concept sheets have to be approved by all participating centres contributing data to the proposed analysis under question. After the participating centres agree to contribute their data and sign a publication agreement, the EPIC-PCD managing centre (University of Bern) will prepare a partial dataset for the proposed analysis and will work closely with the lead researchers offering methodological input and support. In case additional data is collected to complete the partial dataset for a specific project, this will be added to the EPIC-PCD dataset to enrich it after each project.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ciliary Motility Disorders
Kartagener Syndrome
Dyskinesias
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Ciliopathies
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Bronchiectasis
Bronchial Diseases
Respiratory System Abnormalities
Dextrocardia
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Situs Inversus