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Swiss Primary Ciliary Dyskinesia Registry (CH-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: NCT03606200
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
University of Bern

Brief Summary:
The Swiss Primary Ciliary Dyskinesia (PCD) Registry is a national patient registry that collects information on diagnosis, symptoms, treatment and follow-up of patients with PCD in Switzerland and provides data for national and international monitoring and research.

Condition or disease
Primary Ciliary Dyskinesia Kartagener Syndrome

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Other
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





Primary Outcome Measures :
  1. Height [ Time Frame: every 3 months up to 80 years ]
    Height z-scores calculated based on available national and international references

  2. BMI [ Time Frame: every 3 months up to 80 years ]
    Body Mass Index (BMI) z-scores calculated based on available national and international references

  3. 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

  4. 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

  5. Cilia ultrastructure identified using electron microscopy analysis [ Time Frame: at study entry ]
    Results of electron microscopy analysis of cilia, performed for diagnosis

  6. 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

  7. 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).

  8. 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.

  9. Chest computed tomography [ Time Frame: every 3 months up to 80 years ]
    Radiological findings from chest computed tomography

  10. Sinus computed tomography [ Time Frame: every 3 months up to 80 years ]
    Radiological findings from sinus computed tomography

  11. 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?



Information from the National Library of Medicine

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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, who are resident or treated in Switzerland.
Criteria

Inclusion Criteria:

  • Patients diagnosed with primary ciliary dyskinesia
  • Signed informed consent or assent

Exclusion Criteria:

-


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): NCT03606200


Contacts
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Contact: Claudia E Kuehni, Prof 0041 316313507 spcdr@hin.ch
Contact: Myrofora Goutaki, MD-PhD 0041 316315973 spcdr@hin.ch

Locations
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Switzerland
University of Bern Recruiting
Bern, Switzerland, 3012
Contact: Claudia E Kuehni, Prof    0041 316313507    spcdr@hin.ch   
Contact: Myrofora Goutaki, MD-PhD    0041 316315973    spcdr@hin.ch   
Sponsors and Collaborators
University of Bern
Investigators
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Principal Investigator: Claudia E Kuehni, Prof University of Bern
Principal Investigator: Myrofora Goutaki, MD-PhD University of Bern
Additional Information:

Publications of Results:
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Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT03606200    
Other Study ID Numbers: SPCDR
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Anonymised data are shared for international collaborative projects. For requests related to IPD please contact spcdr@hin.ch

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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
Signs and Symptoms
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