Swiss Primary Ciliary Dyskinesia Registry (CH-PCD)
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|ClinicalTrials.gov Identifier: NCT03606200|
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : May 11, 2020
|Condition or disease|
|Primary Ciliary Dyskinesia Kartagener Syndrome|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||800 participants|
|Target Follow-Up Duration:||80 Years|
|Official Title:||Swiss Primary Ciliary Dyskinesia Registry|
|Actual Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2050|
|Estimated Study Completion Date :||December 2050|
- Height [ Time Frame: every 3 months up to 80 years ]Height z-scores calculated based on available national and international references
- BMI [ Time Frame: every 3 months up to 80 years ]Body Mass Index (BMI) z-scores calculated based on available national and international references
- Lung function measurements [ Time Frame: every 3 months up to 80 years ]Spirometric indices, particularly Forced expiratory volume in 1 sec (FEV1) and Forced vital capacity (FVC) z-scores calculated based on Global Lung Function Initiative (GLI) reference values
- Measurement of nasal nitric oxide using breath analyzer [ Time Frame: at study entry (in case patient is <5 years old at study entry, then the outcome will be assessed at age 5 ]Results of nasal nitric oxide measurement, performed for diagnosis
- Cilia ultrastructure identified using electron microscopy analysis [ Time Frame: at study entry ]Results of electron microscopy analysis of cilia, performed for diagnosis
- Ciliary beat frequency and beat pattern using video microscopy analysis [ Time Frame: at study entry ]Results of video microscopy analysis of cilia, performed for diagnosis
- Microbiological culture of respiratory samples [ Time Frame: every 3 months up to 80 years ]Results of microbiology cultures of respiratory samples (sputum, cough swabs, throat swabs, ear swabs, bronchoalveolar lavage) expressed in a qualitative (growth or no growth of pathogens) or semiquantitative way (the type of sample depends on the age of the patient and the clinic the sample was collected).
- Antibiotic resistance of microbes isolated in microbiological cultures [ Time Frame: every 3 months up to 80 years ]Information on antibiotic resistance of microbes isolated in microbiological cultures (see outcome 7) of respiratory samples, expressed either semiquantitavely or by the value of minimum inhibitory concentration.
- Chest computed tomography [ Time Frame: every 3 months up to 80 years ]Radiological findings from chest computed tomography
- Sinus computed tomography [ Time Frame: every 3 months up to 80 years ]Radiological findings from sinus computed tomography
- Vital status [ Time Frame: every 3 months up to 80 years ]Vital status of patient: has the patient died or is he/she still alive and in case of death what was the cause?
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): NCT03606200
|Contact: Claudia E Kuehni, Prof||0041 firstname.lastname@example.org|
|Contact: Myrofora Goutaki, MD-PhD||0041 email@example.com|
|Principal Investigator:||Claudia E Kuehni, Prof||University of Bern|
|Principal Investigator:||Myrofora Goutaki, MD-PhD||University of Bern|